Trial Outcomes & Findings for Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia (NCT NCT00804856)

NCT ID: NCT00804856

Last Updated: 2023-10-03

Results Overview

To determine the Maximum tolerated dose (MTD), dose escalation was conducted following the 3+3 design with de-escalation. The MTD was defined as the highest dose at which 6 patients had been treated and less than 2 patients experienced a Dose limiting toxicity (DLT) within the first cycle of treatment. The MTD was defined based on safety data from the first cycle only. DLT is defined as drug related Common terminology criteria for adverse events (CTCAE) grade ≥ 3 nonhaematological toxicity (excluding: untreated nausea, untreated vomiting, CTCAE grade 3 untreated diarrhoea, CTCAE grade 3 "febrile neutropenia" and CTCAE grade 3 "infection with grade 3 or 4 neutrophils"). In patients with complete remission with incomplete blood count recovery (CRi) or partial remission (PR), persistent CTCAE grade 4 neutropenia or thrombocytopenia until three weeks after the end of the treatment cycle will be regarded a DLT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

180 participants

Primary outcome timeframe

First Treatment cycle, up to 28 days.

Results posted on

2023-10-03

Participant Flow

Open-label, randomized, dose escalation study. In this trial 180 patients were entered and randomised. However 3 patients were entered but not treated in Phase I and 2 patients were not treated in Phase II. Thus total 175 patients were treated in this trial.

Patients were assigned to two treatment schedules (A and B) in the phase I part of the trial (dose escalation phase to determine maximum tolerated dose (MTD)). In the phase IIa part of the trial (after MTD was determined), patients were randomised to two treatment schedules (A and C).

Participant milestones

Participant milestones
Measure
Phase I Schedule A. Volasertib 150 mg+LDAC
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 200 mg+LDAC
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Overall Study
STARTED
4
3
5
9
8
3
11
2
5
6
23
5
4
45
42
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
4
3
5
9
8
3
11
2
5
6
23
5
4
45
42

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase I Schedule A. Volasertib 150 mg+LDAC
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 200 mg+LDAC
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Overall Study
Progressive Disease
3
2
4
6
4
1
8
2
4
5
12
2
2
26
20
Overall Study
Dose Limiting Toxicity (DLT)
0
0
0
0
1
0
0
0
0
0
0
0
0
0
1
Overall Study
Other Adverse Event
1
1
1
2
2
1
3
0
0
1
5
2
0
6
13
Overall Study
Non compliance with protocol
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
Overall Study
Refused to continue medication
0
0
0
1
1
0
0
0
0
0
3
0
1
1
5
Overall Study
Other reason than listed above
0
0
0
0
0
1
0
0
1
0
3
1
1
10
3

Baseline Characteristics

Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase I Schedule A. Volasertib 150 mg+LDAC
n=4 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 200 mg+LDAC
n=3 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase II Schedule C. LDAC
n=45 Participants
Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
n=42 Participants
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total
n=175 Participants
Total of all reporting groups
Age, Continuous
69.5 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
67.0 Years
STANDARD_DEVIATION 3.0 • n=7 Participants
71.2 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
67.9 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
72.5 Years
STANDARD_DEVIATION 6.1 • n=21 Participants
73.3 Years
STANDARD_DEVIATION 7.6 • n=10 Participants
73.5 Years
STANDARD_DEVIATION 3.9 • n=115 Participants
73.0 Years
STANDARD_DEVIATION 4.2 • n=6 Participants
70.6 Years
STANDARD_DEVIATION 2.9 • n=6 Participants
65.2 Years
STANDARD_DEVIATION 20.1 • n=64 Participants
68.2 Years
STANDARD_DEVIATION 7.7 • n=17 Participants
66.4 Years
STANDARD_DEVIATION 7.3 • n=21 Participants
69.8 Years
STANDARD_DEVIATION 4.1 • n=22 Participants
75.2 Years
STANDARD_DEVIATION 5.5 • n=8 Participants
75.6 Years
STANDARD_DEVIATION 4.9 • n=16 Participants
72.5 Years
STANDARD_DEVIATION 7.7 • n=135 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
1 Participants
n=10 Participants
3 Participants
n=115 Participants
1 Participants
n=6 Participants
3 Participants
n=6 Participants
2 Participants
n=64 Participants
16 Participants
n=17 Participants
1 Participants
n=21 Participants
3 Participants
n=22 Participants
20 Participants
n=8 Participants
19 Participants
n=16 Participants
79 Participants
n=135 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
2 Participants
n=10 Participants
8 Participants
n=115 Participants
1 Participants
n=6 Participants
2 Participants
n=6 Participants
4 Participants
n=64 Participants
7 Participants
n=17 Participants
4 Participants
n=21 Participants
1 Participants
n=22 Participants
25 Participants
n=8 Participants
23 Participants
n=16 Participants
96 Participants
n=135 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
1 Participants
n=8 Participants
0 Participants
n=16 Participants
1 Participants
n=135 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
1 Participants
n=8 Participants
1 Participants
n=16 Participants
4 Participants
n=135 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
0 Participants
n=16 Participants
0 Participants
n=135 Participants
Race (NIH/OMB)
Black or African American
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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
0 Participants
n=16 Participants
0 Participants
n=135 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
8 Participants
n=4 Participants
8 Participants
n=21 Participants
3 Participants
n=10 Participants
11 Participants
n=115 Participants
2 Participants
n=6 Participants
5 Participants
n=6 Participants
6 Participants
n=64 Participants
21 Participants
n=17 Participants
5 Participants
n=21 Participants
4 Participants
n=22 Participants
35 Participants
n=8 Participants
34 Participants
n=16 Participants
153 Participants
n=135 Participants
Race (NIH/OMB)
More than one race
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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
0 Participants
n=16 Participants
0 Participants
n=135 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
2 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
8 Participants
n=8 Participants
7 Participants
n=16 Participants
17 Participants
n=135 Participants

PRIMARY outcome

Timeframe: First Treatment cycle, up to 28 days.

Population: Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib (BI 6727) or LDAC (Low-Dose Cytarabine), including patients who were replaced for any reason.

To determine the Maximum tolerated dose (MTD), dose escalation was conducted following the 3+3 design with de-escalation. The MTD was defined as the highest dose at which 6 patients had been treated and less than 2 patients experienced a Dose limiting toxicity (DLT) within the first cycle of treatment. The MTD was defined based on safety data from the first cycle only. DLT is defined as drug related Common terminology criteria for adverse events (CTCAE) grade ≥ 3 nonhaematological toxicity (excluding: untreated nausea, untreated vomiting, CTCAE grade 3 untreated diarrhoea, CTCAE grade 3 "febrile neutropenia" and CTCAE grade 3 "infection with grade 3 or 4 neutrophils"). In patients with complete remission with incomplete blood count recovery (CRi) or partial remission (PR), persistent CTCAE grade 4 neutropenia or thrombocytopenia until three weeks after the end of the treatment cycle will be regarded a DLT.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=32 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=56 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I: Maximum Tolerated Dose (MTD) of Volasertib in Combination With LDAC (Schedule A) and Volasertib Monotherapy (Schedule B)
350 milligram (mg)
450 milligram (mg)

PRIMARY outcome

Timeframe: The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.

Population: Treated set-phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Phase II: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)). Complete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \>100,000/μL. Complete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \<1,000/μL or platelets \<100,000/μL in the blood were not achieved.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=45 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=42 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Number of Patients With Objective Response (Complete Remission (CR) + Complete Remission With Incomplete Blood Count Recovery (CRi))
6 Participants
13 Participants

PRIMARY outcome

Timeframe: First Treatment cycle, up to 28 days.

Population: Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib (BI 6727) or LDAC (Low-Dose Cytarabine), including patients who were replaced for any reason.

A DLT was defined as a drug related CTCAE (Common Toxicity Criteria for Adverse Events) Grade ≥3 non-haematological toxicity (excluding untreated nausea, untreated vomiting, Grade 3 untreated diarrhea, Grade 3 febrile neutropenia, and Grade 3 infection with Grade 3 or 4 neutrophils). In patients with CRi (Complete Remission with Incomplete Blood Count Recovery) or PR (Partial Remission), persistent Grade 4 neutropenia or thrombocytopenia for 3 weeks after the end of the treatment cycle was regarded as a DLT unless the respective Grade 4 cytopenia was preexistent. In patients who required platelet substitution to maintain a Grade \<4 before treatment, a Grade 4 thrombocytopenia after treatment did not constitute a DLT.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=32 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
n=56 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
2 Participants
4 Participants
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
2 Participants
2 Participants
7 Participants

SECONDARY outcome

Timeframe: The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.

Population: Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

* CR * CR+CRi * Partial remission: CR except bone marrow (BM) contained ≥5% but \<25% blasts (or ≤50% initial blasts), or \<5% blasts in presence of Auer rods or abnormal morphology. * No change: survived ≥7 days (d) after 1st cycle with persistent leukemia in last peripheral blood smear or BM, or with persistent extramedullary disease, without further deterioration due to leukemia or increase of blasts in BM or peripheral blood. * Aplasia: survived ≥7d after 1st cycle, died whilst cytopenic, with last post-treatment BM result aplastic or hypoplastic and without leukemia blasts. * Indeterminate: survived \<7 d after 1st cycle or survived ≥7d after 1st cycle, died with no persistent leukemia in peripheral smear but no post-treatment BM examination or did not complete 1st cycle. * Progressive disease: survived ≥7d after 1st cycle with increase of blast population in BM or peripheral blood or aggravation or new extramedullary disease or further deterioration or death due to leukemia.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=32 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
n=56 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
n=45 Participants
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
n=42 Participants
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
n=87 Participants
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Best Overall Response
Complete remission
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
6 Participants
9 Participants
Best Overall Response
CRi
0 Participants
2 Participants
0 Participants
1 Participants
1 Participants
0 Participants
4 Participants
0 Participants
0 Participants
1 Participants
2 Participants
2 Participants
0 Participants
0 Participants
5 Participants
3 Participants
7 Participants
10 Participants
Best Overall Response
Partial remission
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
2 Participants
0 Participants
1 Participants
4 Participants
2 Participants
2 Participants
4 Participants
Best Overall Response
No change
2 Participants
1 Participants
2 Participants
1 Participants
1 Participants
1 Participants
8 Participants
4 Participants
0 Participants
2 Participants
2 Participants
7 Participants
3 Participants
0 Participants
18 Participants
18 Participants
15 Participants
33 Participants
Best Overall Response
Aplasia
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
3 Participants
1 Participants
1 Participants
6 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response
Indeterminate
0 Participants
0 Participants
0 Participants
2 Participants
3 Participants
1 Participants
6 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
3 Participants
5 Participants
8 Participants
Best Overall Response
Progressive disease
2 Participants
0 Participants
1 Participants
3 Participants
3 Participants
1 Participants
10 Participants
6 Participants
2 Participants
1 Participants
1 Participants
7 Participants
1 Participants
1 Participants
19 Participants
14 Participants
7 Participants
21 Participants
Best Overall Response
Not evaluable
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
1 Participants
3 Participants
2 Participants
0 Participants
2 Participants
Best Overall Response
Missing
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 594 days.

Population: Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.

Phase I: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)). Complete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \>100,000/μL. Complete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \<1,000/μL or platelets \<100,000/μL in the blood were not achieved.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=32 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
n=56 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I: Number of Patients With Objective Response: Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR+CRi)
0 Participants
2 Participants
2 Participants
1 Participants
1 Participants
0 Participants
6 Participants
0 Participants
0 Participants
1 Participants
2 Participants
2 Participants
0 Participants
0 Participants
5 Participants

SECONDARY outcome

Timeframe: The patients that entered the trial, and measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, whichever occurred first, up to 1000 days..

Population: Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Event-free survival (EFS) \[days\] was the shortest duration of the following: (a) Date of assessment indicating PD on the response page of the eCRF (Electronic Case Report Form) - date of randomisation + 1 day (b) Date of assessment indicating clinical progressive disease (PD) on the disease or responses pages of the of eCRF- date of randomisation + 1 day (c) Date of assessment indicating PD on the patient status page of the eCRF - date of randomisation +1 day (for patients who had not been censored before this time point) (d) Death date - date of randomisation +1 day Patients not being assessed PD, clinical PD, or death during the trial were censored. EFS was analysed with the Kaplan-Meier method for each of the treatment arms.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=45 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=42 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Event Free Survival
69.0 Days
Interval 27.0 to 215.0
169.0 Days
Interval 39.0 to 470.0

SECONDARY outcome

Timeframe: The patients that entered the trial, and measured from the date of randomisation until death from any cause, up to 1100 days..

Population: Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Overall survival \[days\] = (date of death - date of randomisation + 1 day), for patients with known date of death. Overall survival (censored) \[days\] = (date of last trial visit or follow-up - date of randomisation + 1 day), for patients who were still alive at time of database lock. Overall survival (OS) was analysed with the Kaplan-Meier method for each of the treatment arms.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=45 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=42 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Overall Survival
158.0 Days
Interval 78.0 to 347.0
245.0 Days
Interval 73.0 to 689.0

SECONDARY outcome

Timeframe: The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence or death from any cause, whichever occurred first, up to 900 days.

Population: Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Relapse-free survival \[days\] = (date of first recurrence of disease or death after entering the trial - date of first occurrence of CR or CRi after entering the trial+ 1 day) for patients with a recurrence (this value should be positive). Relapse-free survival (censored) \[days\] = (date of last trial visit or follow-up - date of first occurrence of CR or CRi after entering the trial + 1 day) for patients who did not experience recurrence of disease or death at the time of analysis.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=6 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=13 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Relapse - Free Survival
304.0 Days
Interval 113.0 to 367.0
563.0 Days
Interval 427.0 to
25% quartile not reached, not enough events occurred.

SECONDARY outcome

Timeframe: The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 900 days.

Population: Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Remission duration analysis was defined only for patients who achieved Complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of cause.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=6 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=13 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Remission Duration
367.0 Days
Interval 113.0 to 367.0
687.0 Days
Interval 427.0 to
25% quartile not reached, not enough events occurred.

SECONDARY outcome

Timeframe: The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 158 days.

Population: Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Time to remission \[days\] = (date of first occurrence of CR or CRi after entering the trial-date of randomisation + 1 day) for patients with an objective response.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=6 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=13 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Time to Remission
63.5 Days
Interval 30.0 to 125.0
71.0 Days
Interval 29.0 to 158.0

SECONDARY outcome

Timeframe: Baseline and End of Treatment (up to 869 days).

Population: Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC. Only participants with non-missing values are reported.

ECOG performance score change from baseline to last visit of last cycle = ECOG performance score at last visit of the last cycle - ECOG performance score at baseline. ECOG performance score changes from baseline were also categorised on a 3-point categorical scale: deteriorated (-1), unchanged (0), and improved (1). The number of participants for category of ECOG score change is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=5 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=2 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=27 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=10 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=22 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=3 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
n=53 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
n=42 Participants
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
n=39 Participants
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
n=81 Participants
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment
Unchanged
3 Participants
1 Participants
5 Participants
2 Participants
5 Participants
1 Participants
17 Participants
9 Participants
1 Participants
0 Participants
4 Participants
14 Participants
2 Participants
3 Participants
33 Participants
22 Participants
15 Participants
37 Participants
Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment
Improved
0 Participants
2 Participants
0 Participants
1 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
1 Participants
1 Participants
3 Participants
1 Participants
0 Participants
6 Participants
8 Participants
13 Participants
21 Participants
Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment
Deteriorated
1 Participants
0 Participants
0 Participants
2 Participants
3 Participants
1 Participants
7 Participants
1 Participants
1 Participants
4 Participants
1 Participants
5 Participants
2 Participants
0 Participants
14 Participants
12 Participants
11 Participants
23 Participants

SECONDARY outcome

Timeframe: Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.

Population: Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1. Phase I Schedule B Volasertib 200mg+LDAC was not analysed as there was not enough plasma concentrations at the terminal phase of the curve to calculate the half-life for one of the two subjects.

Total Clearance (CL) of Volasertib in Plasma after Intravenous (i.v.) Administration of Volasertib.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=8 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=10 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=1 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=5 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=6 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=22 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=5 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=3 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=31 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Clearance (CL) of Volasertib in Plasma After i.v (Intravenous) Administration of Volasertib
1280 millilitre/minute (mL/min)
Geometric Coefficient of Variation 52.8
972 millilitre/minute (mL/min)
Geometric Coefficient of Variation 26.6
864 millilitre/minute (mL/min)
Geometric Coefficient of Variation 27.6
1150 millilitre/minute (mL/min)
Geometric Coefficient of Variation 34.4
1000 millilitre/minute (mL/min)
Geometric Coefficient of Variation 36.2
852 millilitre/minute (mL/min)
Geometric Coefficient of Variation 49.6
1330 millilitre/minute (mL/min)
Geometric Coefficient of Variation 29.3
NA millilitre/minute (mL/min)
Geometric Coefficient of Variation NA
Not calculable with one subject
810 millilitre/minute (mL/min)
Geometric Coefficient of Variation 35.1
1120 millilitre/minute (mL/min)
Geometric Coefficient of Variation 62.1
920 millilitre/minute (mL/min)
Geometric Coefficient of Variation 36.2
1140 millilitre/minute (mL/min)
Geometric Coefficient of Variation 38.5
939 millilitre/minute (mL/min)
Geometric Coefficient of Variation 93.2
897 millilitre/minute (mL/min)
Geometric Coefficient of Variation 42.8

SECONDARY outcome

Timeframe: Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.

Population: Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1. Phase I Schedule B Volasertib 200mg+LDAC was not analysed as there was not enough plasma concentrations at the terminal phase of the curve to calculate the half-life for one of the two subjects.

Apparent Volume of Distribution of volasertib at steady state (VSS) following Intravenous (i.v.) administration.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=8 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=10 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=1 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=5 Participants
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=6 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=22 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=5 Participants
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=3 Participants
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=31 Participants
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Apparent Volume of Distribution of Volasertib at Steady State (VSS)
10600 Liter (L)
Geometric Coefficient of Variation 111.0
8640 Liter (L)
Geometric Coefficient of Variation 14.1
7000 Liter (L)
Geometric Coefficient of Variation 26.6
6320 Liter (L)
Geometric Coefficient of Variation 35.9
5270 Liter (L)
Geometric Coefficient of Variation 58.2
4830 Liter (L)
Geometric Coefficient of Variation 56.7
10300 Liter (L)
Geometric Coefficient of Variation 36.3
NA Liter (L)
Geometric Coefficient of Variation NA
Not calculable with one subject
5800 Liter (L)
Geometric Coefficient of Variation 35.1
7150 Liter (L)
Geometric Coefficient of Variation 70.6
5740 Liter (L)
Geometric Coefficient of Variation 38.7
6360 Liter (L)
Geometric Coefficient of Variation 50.1
5680 Liter (L)
Geometric Coefficient of Variation 81.9
6130 Liter (L)
Geometric Coefficient of Variation 42.0

SECONDARY outcome

Timeframe: Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.

Population: Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1, Only participants with non-missing values are reported.

Cmax, norm: Maximum measured concentration of Cytarabine in plasma. The dose normalisation was done by dividing by the dose applied. Unit: nanogram/milliliter/milligram: ((ng/mL)/mg). Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=32 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=41 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=40 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Dose Normalized Maximum Measured Concentration of Cytarabine in Plasma (Cmax, Norm)
2.92 (ng/mL)/mg
Geometric Coefficient of Variation 61.3
2.83 (ng/mL)/mg
Geometric Coefficient of Variation 52.8
2.36 (ng/mL)/mg
Geometric Coefficient of Variation 77.6

SECONDARY outcome

Timeframe: Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h after first drug administration.

Population: Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1.

AUC0-4,norm: Area under the concentration-time curve of Cytarabine in plasma over the time interval from zero extrapolated to 4 hours. The dose normalisation was done by dividing by dose applied. Unit: nanogram\*hour/milliliter/milligram: ((ng\*h/mL)/mg). Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=32 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=41 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=40 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Dose Normalized Area Under the Concentration-Time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated up to 4 Hours
3.84 (ng*h/mL)/mg
Geometric Coefficient of Variation 30.6
4.00 (ng*h/mL)/mg
Geometric Coefficient of Variation 35.6
3.94 (ng*h/mL)/mg
Geometric Coefficient of Variation 43.8

SECONDARY outcome

Timeframe: Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.

Population: Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Only participants with non-missing values are reported.

ECG (Electro Cardio Gram) Measurements: Absolute QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) Corrected for Heart Rate Using Fridericia's Formula) Intervals. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=50 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=23 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals
Individual baseline
411.6 milliseconds (ms)
Standard Deviation 20.7
412.4 milliseconds (ms)
Standard Deviation 18.7
Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals
1 hour after start of infusion
430.0 milliseconds (ms)
Standard Deviation 20.4
441.1 milliseconds (ms)
Standard Deviation 20.0
Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals
24 hour after start of infusion
414.0 milliseconds (ms)
Standard Deviation 21.3
411.9 milliseconds (ms)
Standard Deviation 18.4

SECONDARY outcome

Timeframe: Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.

Population: Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Only participants with non-missing values are reported.

ECG Measurements: QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) changes from baseline at each time point: The QTcF post baseline measurement obtained at time t minus baseline QTcF measurement. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=50 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=23 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Change From Baseline at Cycle 1
Change from baseline after 1 hour
18.5 millisecond (ms)
Standard Deviation 10.4
29.6 millisecond (ms)
Standard Deviation 8.1
QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Change From Baseline at Cycle 1
Change from baseline after 24 hour
1.9 millisecond (ms)
Standard Deviation 10.5
-0.5 millisecond (ms)
Standard Deviation 9.8

SECONDARY outcome

Timeframe: First treatment cycle, up to 28 days.

Population: Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.

Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=32 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 3
0 Participants
0 Participants
1 Participants
1 Participants
2 Participants
1 Participants
5 Participants
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 4
2 Participants
3 Participants
3 Participants
5 Participants
3 Participants
1 Participants
17 Participants
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 5
0 Participants
0 Participants
0 Participants
3 Participants
2 Participants
1 Participants
6 Participants

SECONDARY outcome

Timeframe: First treatment cycle, up to 28 days.

Population: Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.

Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=11 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=2 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=6 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=23 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=5 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=4 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=56 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 3
5 Participants
0 Participants
1 Participants
0 Participants
5 Participants
0 Participants
0 Participants
11 Participants
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 4
4 Participants
1 Participants
3 Participants
4 Participants
14 Participants
1 Participants
3 Participants
30 Participants
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1
Grade 5
1 Participants
1 Participants
0 Participants
0 Participants
2 Participants
1 Participants
1 Participants
6 Participants

SECONDARY outcome

Timeframe: From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 615 days.

Population: Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.

Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=4 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=3 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=32 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 3
1 Participants
0 Participants
0 Participants
1 Participants
2 Participants
1 Participants
5 Participants
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 4
1 Participants
3 Participants
5 Participants
5 Participants
3 Participants
1 Participants
18 Participants
Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 5
1 Participants
0 Participants
0 Participants
3 Participants
2 Participants
1 Participants
7 Participants

SECONDARY outcome

Timeframe: From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 597 days.

Population: Treated set-Phase I part: the treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.

Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=11 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=2 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 Participants
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=6 Participants
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=23 Participants
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=5 Participants
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
n=4 Participants
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=56 Participants
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 3
5 Participants
0 Participants
1 Participants
0 Participants
3 Participants
0 Participants
0 Participants
9 Participants
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 4
4 Participants
1 Participants
3 Participants
5 Participants
15 Participants
1 Participants
3 Participants
32 Participants
Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 5
2 Participants
1 Participants
0 Participants
0 Participants
3 Participants
2 Participants
1 Participants
9 Participants

SECONDARY outcome

Timeframe: From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 890 days.

Population: Treated set-Phase II part: the treated set (Phase II) was defined as all patients in Phase II who received at least a single dose of either Volasertib or LDAC.

Number of patients with AEs following in the in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.

Outcome measures

Outcome measures
Measure
Phase I Schedule A. Volasertib+LDAC
n=45 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.
Phase I Schedule B. Volasertib
n=42 Participants
Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period
Phase I Schedule A. Volasertib 250 mg+LDAC
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Total Phase I Combined. Schedule A.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Total Phase I Combined. Schedule B.
Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.
Phase II Schedule C. LDAC
Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Total Phase II Combined. Schedule A and C.
Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 4
13 Participants
20 Participants
Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 5
6 Participants
8 Participants
Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles
Grade 3
13 Participants
12 Participants

Adverse Events

Phase II Schedule C. LDAC

Serious events: 29 serious events
Other events: 43 other events
Deaths: 45 deaths

Phase I Schedule A. Volasertib 150 mg+LDAC

Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths

Phase I Schedule A. Volasertib 200 mg+LDAC

Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths

Phase I Schedule A. Volasertib 250 mg+LDAC

Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths

Phase I Schedule A. Volasertib 300 mg+LDAC

Serious events: 7 serious events
Other events: 9 other events
Deaths: 9 deaths

Phase I Schedule A. Volasertib 350 mg+LDAC

Serious events: 6 serious events
Other events: 8 other events
Deaths: 8 deaths

Phase II Schedule A. Volasertib 350 mg+LDAC

Serious events: 34 serious events
Other events: 41 other events
Deaths: 38 deaths

Phase I Schedule A. Volasertib 400 mg+LDAC

Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths

Phase I Schedule B. Volasertib 150 mg

Serious events: 7 serious events
Other events: 11 other events
Deaths: 11 deaths

Phase I Schedule B. Volasertib 200 mg

Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths

Phase I Schedule B. Volasertib 350 mg

Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths

Phase I Schedule B. Volasertib 400 mg

Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths

Phase I Schedule B. Volasertib 450 mg

Serious events: 16 serious events
Other events: 23 other events
Deaths: 21 deaths

Phase I Schedule B. Volasertib 500 mg

Serious events: 3 serious events
Other events: 5 other events
Deaths: 5 deaths

Phase I Schedule B. Volasertib 550 mg

Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Phase II Schedule C. LDAC
n=45 participants at risk
Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase I Schedule A. Volasertib 150 mg+LDAC
n=4 participants at risk
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 200 mg+LDAC
n=3 participants at risk
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 participants at risk
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 participants at risk
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
n=42 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 participants at risk
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 participants at risk
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 participants at risk
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 participants at risk
Phase I Schedule B. Volasertib 400 mg Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 participants at risk
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 participants at risk
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 participants at risk
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Blood and lymphatic system disorders
Anaemia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Bone marrow failure
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Febrile bone marrow aplasia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Febrile neutropenia
13.3%
6/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
54.8%
23/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
39.1%
9/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Pancytopenia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Thrombocytopenia
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Acute coronary syndrome
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Acute myocardial infarction
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Angina pectoris
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Angina unstable
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Arrhythmia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac failure
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac failure congestive
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Long QT syndrome
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Myocardial infarction
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Myocardial ischaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Ventricular fibrillation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Ear and labyrinth disorders
Vertigo
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Abdominal pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Anal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Constipation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Diarrhoea
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastrointestinal disorder
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Ileus
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Tongue haematoma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Vomiting
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Asthenia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Chest pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
General physical health deterioration
11.1%
5/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Hypothermia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Mucosal haemorrhage
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Mucosal inflammation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Pyrexia
17.8%
8/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatic failure
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Immune system disorders
Hypersensitivity
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Abscess
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Abscess neck
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Arthritis bacterial
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Aspergillus infection
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Bacterial pyelonephritis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Bronchitis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Cellulitis
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Cerebral fungal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Clostridium difficile infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Cystitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Device related infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Endocarditis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Erysipelas
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Escherichia sepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Gastroenteritis norovirus
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Herpes zoster
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Infection
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Lung infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Neutropenic sepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pneumonia
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
19.0%
8/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pneumonia fungal
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pseudomembranous colitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pseudomonal sepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pulmonary mycosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Sepsis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Soft tissue infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Staphylococcal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Stenotrophomonas infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Tonsillitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Urinary tract infection
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Urosepsis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Meniscus injury
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Brain natriuretic peptide increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
C-reactive protein increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Oxygen saturation decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Dehydration
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Back pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Bone pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Crystal arthropathy
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Osteoarthritis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Polyarthritis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Dizziness
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Headache
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Hypoaesthesia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Neuralgia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Somnolence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Syncope
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Acute psychosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Confusional state
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Depression
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Dysuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Nephropathy
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Renal failure
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Urinary retention
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Hyperventilation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Surgical and medical procedures
Catheterisation venous
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Circulatory collapse
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Deep vein thrombosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Haemorrhage
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Hypotension
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastritis erosive
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Nausea
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Oedema peripheral
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Klebsiella sepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Seizure
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Other adverse events

Other adverse events
Measure
Phase II Schedule C. LDAC
n=45 participants at risk
Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.
Phase I Schedule A. Volasertib 150 mg+LDAC
n=4 participants at risk
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 200 mg+LDAC
n=3 participants at risk
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 250 mg+LDAC
n=5 participants at risk
Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 300 mg+LDAC
n=9 participants at risk
Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 350 mg+LDAC
n=8 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase II Schedule A. Volasertib 350 mg+LDAC
n=42 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule A. Volasertib 400 mg+LDAC
n=3 participants at risk
Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.
Phase I Schedule B. Volasertib 150 mg
n=11 participants at risk
Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 200 mg
n=2 participants at risk
Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 350 mg
n=5 participants at risk
Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 400 mg
n=6 participants at risk
Phase I Schedule B. Volasertib 400 mg Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 450 mg
n=23 participants at risk
Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 500 mg
n=5 participants at risk
Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Phase I Schedule B. Volasertib 550 mg
n=4 participants at risk
Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).
Gastrointestinal disorders
Proctalgia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Small intestine ulcer
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Stomatitis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Tongue coated
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Toothache
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Vomiting
13.3%
6/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
38.1%
16/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Adverse drug reaction
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Leukocytosis
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Angina pectoris
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Anaemia
26.7%
12/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
6/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
14/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
5/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
4/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
47.8%
11/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Febrile neutropenia
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
19.0%
8/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Leukopenia
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
55.6%
5/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
30.4%
7/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Neutropenia
11.1%
5/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.2%
11/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
52.2%
12/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Splenomegaly
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Macular degeneration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Thrombocytopenia
17.8%
8/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
55.6%
5/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.4%
9/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
45.5%
5/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
52.2%
12/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Aortic valve incompetence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Arteriosclerosis coronary artery
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Atrioventricular block
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Bradycardia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Bundle branch block right
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac arrest
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac failure
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiac valve disease
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiomegaly
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiomyopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Cardiovascular disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Congestive cardiomyopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Extrasystoles
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Heart valve incompetence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Hypertensive heart disease
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Left ventricular hypertrophy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Mitral valve incompetence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Palpitations
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Pericardial effusion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Tachyarrhythmia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Tachycardia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Tricuspid valve incompetence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Ventricular extrasystoles
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Ear and labyrinth disorders
Ear haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Ear and labyrinth disorders
Vertigo
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Endocrine disorders
Adrenal disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Cataract
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Dry eye
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Erythema of eyelid
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Eye haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Eyelid oedema
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Glaucoma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Lacrimation increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Visual acuity reduced
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Visual impairment
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Abdominal pain
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Abdominal pain upper
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Abnormal faeces
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Anal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Oesophagitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Ascites
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Constipation
26.7%
12/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
3/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
42.9%
18/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Diarrhoea
24.4%
11/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
31.0%
13/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Dry mouth
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Dyspepsia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Dysphagia
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Enterocolitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Faecaloma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Flatulence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
4/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastritis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastrointestinal inflammation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gingival bleeding
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gingival discolouration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gingival pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gingival swelling
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Glossodynia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Haematochezia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Mouth haemorrhage
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Mouth ulceration
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Nausea
35.6%
16/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
4/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
45.2%
19/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
30.4%
7/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Oral mucosal erythema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Oral pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Periodontal disease
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Asthenia
24.4%
11/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
23.8%
10/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Calcinosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Catheter site erythema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Catheter site oedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Chest discomfort
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Chest pain
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Chills
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Fatigue
24.4%
11/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
5/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
55.6%
5/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
4/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.2%
11/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Feeling cold
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Pyrexia
17.8%
8/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
31.0%
13/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Feeling hot
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Feeling of body temperature change
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Thirst decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Gait disturbance
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
General physical health deterioration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
56.5%
13/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Granuloma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Induration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Inflammation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Influenza like illness
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Infusion site pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Injection site haematoma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Injection site reaction
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Local swelling
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Localised oedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Malaise
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Mucosal inflammation
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
23.8%
10/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Oedema
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Oedema mucosal
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Device related infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Oedema peripheral
20.0%
9/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
55.6%
5/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
28.6%
12/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
39.1%
9/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Pain
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Puncture site pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatic congestion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatic cyst
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatic lesion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatomegaly
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Bacterial infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Beta haemolytic streptococcal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Bronchitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Candida infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Clostridium difficile infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Cystitis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Diverticulitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Enterococcal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Erysipelas
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Escherichia bacteraemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Wound
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Escherichia infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Fungal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Fungal skin infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Fusobacterium infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Gingivitis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Herpes simplex
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Herpes virus infection
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Herpes zoster
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Micrococcus infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Nail bed infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Nasopharyngitis
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Oral candidiasis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Oral herpes
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pharyngitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Excoriation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pneumonia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pneumonia fungal
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Pseudomonas infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Sepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Skin infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Staphylococcal infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Urinary tract infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Urosepsis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood lactate dehydrogenase decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Allergic transfusion reaction
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Drug administration error
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Fall
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Laceration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Lip injury
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Procedural pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Transfusion reaction
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Activated partial thromboplastin time shortened
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Alanine aminotransferase increased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
3/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Aspartate aminotransferase increased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blast cell count increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood albumin decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood albumin increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood alkaline phosphatase increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood bilirubin increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood chloride increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood creatine phosphokinase decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood creatine phosphokinase increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood creatinine
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood creatinine decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood creatinine increased
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
3/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood fibrinogen increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood glucose increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood iron decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood iron increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood phosphorus decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood potassium decreased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood pressure increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood triglycerides increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood urea decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood urea increased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood uric acid increased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Blood urine present
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Body temperature increased
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Protein total decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Prothrombin time prolonged
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Breath sounds abnormal
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
C-reactive protein increased
11.1%
5/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
4/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
30.4%
7/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
75.0%
3/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Candida test positive
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Ejection fraction decreased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Electrocardiogram QT prolonged
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Electrocardiogram change
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Enterococcus test positive
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Escherichia test positive
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Heart rate increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Hepatic enzyme increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Liver function test abnormal
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Oxygen saturation decreased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Prostatic specific antigen increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Serum ferritin increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Thrombin time shortened
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Troponin T increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Troponin increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Weight decreased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
Weight increased
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
White blood cells urine
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Acidosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Alkalosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Decreased appetite
13.3%
6/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
55.6%
5/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
14.3%
6/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
27.3%
3/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
43.5%
10/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Dehydration
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hyperglycaemia
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypernatraemia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hyperuricaemia
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypocalcaemia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypokalaemia
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
75.0%
6/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
19.0%
8/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
3/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
43.5%
10/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Iron overload
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Uraemic acidosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Arthralgia
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
3/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
7/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Arthritis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Back pain
22.2%
10/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
14.3%
6/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Bone lesion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Bone pain
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Flank pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Joint swelling
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Muscle spasms
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Muscular weakness
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Myalgia
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Myopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Osteolysis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Osteoporosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Pain in extremity
13.3%
6/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
3/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Burning sensation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Dizziness
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
80.0%
4/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Headache
15.6%
7/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Hemiparesis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Orthostatic intolerance
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Paraesthesia
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Peripheral sensory neuropathy
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Polyneuropathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Sinus headache
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Somnolence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Syncope
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Tremor
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Agitation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Anxiety
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Communication disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Confusional state
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Depressed mood
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Depression
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Disorientation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Hallucination
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Hallucination, visual
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Initial insomnia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Insomnia
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Panic attack
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Restlessness
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Sleep disorder
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Psychiatric disorders
Suicidal ideation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Anuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Bladder pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Dysuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Haematuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Glycosuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Leukocyturia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Micturition disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Nephropathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Nocturia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Pollakiuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Proteinuria
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Renal atrophy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Renal cyst
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Renal impairment
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Renal pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Urethral haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Urethral pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Urinary incontinence
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Urinary retention
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Breast enlargement
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Genital swelling
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Haematospermia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Nipple disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Skin erosion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Penile oedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Scrotal oedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Vulvovaginal erythema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Cough
13.3%
6/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
23.8%
10/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
26.1%
6/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Dysphonia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.8%
8/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
23.8%
10/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
60.0%
3/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Epistaxis
20.0%
9/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
3/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
38.1%
16/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Hiccups
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.9%
5/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
44.4%
4/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Sputum retention
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Blood blister
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
100.0%
2/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Dry skin
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
3/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Hyperhidrosis
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Night sweats
6.7%
3/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Parapsoriasis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Petechiae
11.1%
5/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
23.8%
10/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
2/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
36.4%
4/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
66.7%
4/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Pruritus
15.6%
7/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.5%
4/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Purpura
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Rash
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
17.4%
4/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Skin haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Skin lesion
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Urticaria
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Social circumstances
Fasting
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Surgical and medical procedures
Central venous catheterisation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Surgical and medical procedures
Nail operation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Angiopathy
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Circulatory collapse
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Haematoma
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
37.5%
3/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
18.2%
2/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
1/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
3/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
13.0%
3/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
40.0%
2/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Hypertension
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
21.7%
5/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
50.0%
2/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Hypertensive crisis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
1/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Hypotension
4.4%
2/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
7/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Infarction
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Peripheral coldness
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Peripheral embolism
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Thrombophlebitis
8.9%
4/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
16.7%
1/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
8.7%
2/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Varicose vein
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
9.1%
1/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Blood and lymphatic system disorders
Cytopenia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
2/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Anal incontinence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Aphthous ulcer
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
7.1%
3/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Tongue discolouration
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Peripheral swelling
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
20.0%
1/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
22.2%
2/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.8%
2/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
33.3%
1/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
11.1%
1/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Arrhythmia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Cardiac disorders
Atrial fibrillation
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Hyphaema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Eye disorders
Photopsia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Palatal disorder
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Gastrointestinal disorders
Tongue haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Catheter site pain
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Discomfort
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Hyperthermia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
General disorders
Mucosal haemorrhage
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Osteomyelitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Post procedural infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Infections and infestations
Soft tissue infection
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Injury, poisoning and procedural complications
Stoma site haemorrhage
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Investigations
International normalised ratio increased
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Metabolism and nutrition disorders
Fluid overload
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Ageusia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Dysgeusia
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Nervous system disorders
Hypotonia
2.2%
1/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
25.0%
2/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
4.3%
1/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Incontinence
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Renal and urinary disorders
Micturition urgency
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Reproductive system and breast disorders
Genital burning sensation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Rales
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Rhonchi
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Skin and subcutaneous tissue disorders
Intertrigo
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Lymphoedema
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
Vascular disorders
Phlebitis
0.00%
0/45 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/9 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
12.5%
1/8 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
2.4%
1/42 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/3 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/11 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/2 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/6 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/23 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/5 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.
0.00%
0/4 • From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.
Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.

Additional Information

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Phone: 1800-243-0127

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.
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Restriction type: OTHER