Trial Outcomes & Findings for Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2) (NCT NCT01721876)

NCT ID: NCT01721876

Last Updated: 2023-02-08

Results Overview

OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 666 participants
• Primary outcome timeframe: Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.
• Results posted on: 2023-02-08

Participant Flow

Patients aged 65 years or more with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy were recruited in the phase III randomised, double-blind, placebo-controlled, parallel group study.

All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.

Participant milestones

Measure	Placebo + Low-dose Cytarabine Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Overall Study STARTED	222	444
Overall Study Treated	221	440
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	222	444

Reasons for withdrawal

Measure	Placebo + Low-dose Cytarabine Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Overall Study Not treated	1	4
Overall Study Disease progression / relapse	123	156
Overall Study Death	6	13
Overall Study Adverse Event	41	165
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	15	38
Overall Study Reason not listed	34	63
Overall Study Sponsor terminated trial	0	4

Baseline Characteristics

Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

Baseline characteristics by cohort

Measure	Placebo + Low-dose Cytarabine n=222 Participants Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine n=444 Participants Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Total n=666 Participants Total of all reporting groups
Age, Continuous	75.5 Years STANDARD_DEVIATION 4.9 • n=93 Participants	75.2 Years STANDARD_DEVIATION 5.4 • n=4 Participants	75.3 Years STANDARD_DEVIATION 5.2 • n=27 Participants
Sex: Female, Male Female	87 Participants n=93 Participants	203 Participants n=4 Participants	290 Participants n=27 Participants
Sex: Female, Male Male	135 Participants n=93 Participants	241 Participants n=4 Participants	376 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=93 Participants	399 Participants n=4 Participants	593 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=93 Participants	29 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	39 Participants n=93 Participants	74 Participants n=4 Participants	113 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	158 Participants n=93 Participants	328 Participants n=4 Participants	486 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=93 Participants	38 Participants n=4 Participants	63 Participants n=27 Participants

PRIMARY outcome

Timeframe: Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.

Population: The randomised set (RS) included all patients who had been randomised at the database snapshot.

OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.

Outcome measures

Measure	Placebo + Low-dose Cytarabine n=222 Participants Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine n=444 Participants Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Objective Response (OR)	38 Participants	123 Participants

SECONDARY outcome

Timeframe: From randomization until death due to any cause, up to 1557 days.

Population: RS

OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.

Outcome measures

Measure	Placebo + Low-dose Cytarabine n=222 Participants Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine n=444 Participants Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Overall Survival (OS)	6.5 Months Interval 4.9 to 8.0	5.6 Months Interval 4.5 to 6.8

SECONDARY outcome

Timeframe: From randomization until disease progression or relapse or death from any cause, up to 1557 days.

Population: RS

EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.

Outcome measures

Measure	Placebo + Low-dose Cytarabine n=222 Participants Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine n=444 Participants Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Event-free Survival (EFS)	2.8 Months Interval 2.1 to 4.9	3.3 Months Interval 2.6 to 4.2

SECONDARY outcome

Timeframe: From randomization until disease progression or relapse or death from any cause, up to 1557 days.

Population: All patients in the RS who achieved best overall response of CR or CRi.

RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.

Outcome measures

Measure	Placebo + Low-dose Cytarabine n=38 Participants Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Volasertib + Low-dose Cytarabine n=123 Participants Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Relapse-free Survival (RFS)	18.7 Months Interval 11.3 to Confidence limits for the quartiles cannot be estimated due to insufficient number of participants with events.	13.1 Months Interval 6.2 to Confidence limits for the quartiles cannot be estimated due to insufficient number of participants with events.

Adverse Events

Subjects Assigned to Placebo + Low-dose Cytarabine

Serious events: 163 serious events

Other events: 203 other events

Deaths: 40 deaths

Subjects Assigned to Volasertib + Low-dose Cytarabine

Serious events: 380 serious events

Other events: 404 other events

Deaths: 138 deaths

Serious adverse events

Measure	Subjects Assigned to Placebo + Low-dose Cytarabine n=222 participants at risk Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Subjects Assigned to Volasertib + Low-dose Cytarabine n=439 participants at risk Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Infections and infestations Influenza	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Klebsiella infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Anaemia	4.5% 10/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	4.6% 20/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Febrile neutropenia	18.9% 42/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	46.2% 203/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Haemorrhagic disorder	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Hypofibrinogenaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Leukocytosis	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Leukopenia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Lymphadenitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Lymphadenopathy	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Neutropenia	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	3.0% 13/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Splenic infarction	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Thrombocytopenia	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.2% 23/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Acute coronary syndrome	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Acute myocardial infarction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Angina unstable	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Arrhythmia	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Atrial fibrillation	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.4% 6/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Atrial flutter	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Bradyarrhythmia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiac arrest	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiac disorder	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiac failure	3.6% 8/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	2.3% 10/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiac failure acute	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiac failure congestive	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardio-respiratory arrest	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiogenic shock	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Cardiopulmonary failure	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Coronary artery disease	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Left ventricular dysfunction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Myocardial infarction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Myocardial ischaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Right ventricular failure	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Supraventricular tachycardia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Tachyarrhythmia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Ventricular fibrillation	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Ventricular tachycardia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Congenital, familial and genetic disorders Aplasia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Endocrine disorders Hyperthyroidism	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Eye disorders Blindness transient	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Eye disorders Retinal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Abdominal pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Abdominal pain upper	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Anal ulcer	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Ascites	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Colitis	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Diarrhoea	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.8% 8/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Enteritis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Enterocolitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Gastric haemorrhage	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Gastritis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Gingival bleeding	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Haematochezia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Haemorrhoids	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Ileus	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Ileus paralytic	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Inguinal hernia strangulated	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Intestinal perforation	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Large intestinal haemorrhage	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Large intestine perforation	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Melaena	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Mouth ulceration	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Odynophagia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Oesophagitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Oral pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Pancreatitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Rectal haemorrhage	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Rectal ulcer	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Stomatitis	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.4% 6/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Vomiting	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Asthenia	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.4% 6/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Catheter site phlebitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Chest pain	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Death	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Device related thrombosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Fatigue	2.3% 5/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders General physical health deterioration	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	3.4% 15/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Induration	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Malaise	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Mucosal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Mucosal inflammation	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Multiple organ dysfunction syndrome	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Oedema peripheral	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Performance status decreased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Pyrexia	8.6% 19/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	7.5% 33/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Sudden death	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Bile duct stone	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Cholecystitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Cholelithiasis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Hepatic failure	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Hepatic function abnormal	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Liver injury	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Immune system disorders Allergy to vaccine	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Immune system disorders Anaphylactic reaction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Immune system disorders Hypersensitivity	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Anal abscess	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Anal infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Appendicitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Aspergillus infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Atypical pneumonia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bacillus infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bacteraemia	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bacterial infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bacterial sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bronchitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Bronchopulmonary aspergillosis	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	2.7% 12/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Campylobacter sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Catheter site infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Cellulitis	2.7% 6/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Clostridium colitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Clostridium difficile infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Colonic abscess	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Conjunctivitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Cystitis	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Device related infection	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Diverticulitis	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enteritis infectious	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enterobacter infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enterobacter sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enterococcal bacteraemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enterococcal sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Enterocolitis infectious	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Epididymitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Erysipelas	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Escherichia bacteraemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Escherichia infection	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Escherichia sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Escherichia urinary tract infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Fungal infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Fungal sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Fungal skin infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Gastroenteritis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Genital herpes	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Klebsiella sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Laryngitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Liver abscess	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Localised infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Lower respiratory tract infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Lymphadenitis bacterial	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Myocarditis septic	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Neutropenic infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.6% 7/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Neutropenic sepsis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Oral candidiasis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Oral herpes	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Osteomyelitis fungal	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Parotitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Perichondritis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pharyngitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pharyngotonsillitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia	19.8% 44/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	25.7% 113/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia fungal	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.6% 7/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia klebsiella	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia staphylococcal	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Prostatitis Escherichia coli	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pseudomembranous colitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pseudomonal sepsis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pseudomonas infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pulmonary sepsis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pulmonary tuberculosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Rash pustular	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Respiratory tract infection	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.6% 7/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Respiratory tract infection fungal	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Respiratory tract infection viral	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Sepsis	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	10.0% 44/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Septic shock	4.5% 10/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.4% 28/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Sinusitis	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Sinusitis aspergillus	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Sinusitis fungal	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Skin infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Soft tissue infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Staphylococcal infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Staphylococcal sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Stenotrophomonas sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Streptococcal sepsis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Subcutaneous abscess	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Testicular abscess	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Tonsillitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Tonsillitis bacterial	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Tooth infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Tuberculosis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Upper respiratory tract infection	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Urinary tract infection	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	2.7% 12/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Urosepsis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Vulvitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Concussion	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Craniocerebral injury	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Fall	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Humerus fracture	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Infusion related reaction	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Pelvic fracture	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Subdural haematoma	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Transfusion-related circulatory overload	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Alanine aminotransferase increased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Blood bilirubin increased	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Blood creatinine increased	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Blood pressure orthostatic decreased	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations C-reactive protein increased	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Electrocardiogram QT prolonged	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Haematocrit decreased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Haemoglobin decreased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Liver function test abnormal	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Platelet count decreased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Troponin increased	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations White blood cell count increased	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Acidosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Cachexia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Decreased appetite	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Dehydration	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Fluid overload	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hyperglycaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hyperkalaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypoglycaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypokalaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Metabolic acidosis	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Arthralgia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Arthritis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Neck pain	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of thorax	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	7.7% 17/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.0% 22/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Brain stem haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Cerebellar haemorrhage	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Cerebral haemorrhage	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Cerebral infarction	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Cerebral ischaemia	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Cerebrovascular accident	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Dizziness	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Embolic cerebral infarction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Epilepsy	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Haemorrhage intracranial	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Haemorrhagic stroke	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Hemiparesis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Hypotonia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Seizure	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Sneddon's syndrome	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Spinal cord compression	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Stupor	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Syncope	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Transient ischaemic attack	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Psychiatric disorders Confusional state	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Psychiatric disorders Disorientation	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Psychiatric disorders Mental disorder	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Acute kidney injury	3.2% 7/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	4.3% 19/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Bladder obstruction	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Haematuria	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Renal failure	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.4% 6/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Renal impairment	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Ureterolithiasis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Renal and urinary disorders Urinary retention	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.4% 6/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.91% 4/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.7% 6/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	2.5% 11/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Surgical and medical procedures Angioplasty	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Deep vein thrombosis	1.4% 3/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	1.1% 5/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Embolism	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Haematoma	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypertension	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypertensive emergency	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypotension	0.90% 2/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypovolaemic shock	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Orthostatic hypotension	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Peripheral artery thrombosis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Phlebitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Thrombophlebitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Venous thrombosis limb	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Cardiac disorders Atrioventricular block	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Diverticulum	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Hepatobiliary disorders Hepatic cytolysis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Clostridium bacteraemia	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Clostridium difficile colitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Haematoma infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Large intestine infection	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Nasopharyngitis	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia influenzal	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia pseudomonal	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Vascular device infection	0.45% 1/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.00% 0/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.68% 3/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Rash	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.46% 2/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Aortitis	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	0.23% 1/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.

Other adverse events

Measure	Subjects Assigned to Placebo + Low-dose Cytarabine n=222 participants at risk Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.	Subjects Assigned to Volasertib + Low-dose Cytarabine n=439 participants at risk Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
Blood and lymphatic system disorders Anaemia	23.9% 53/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	31.2% 137/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Febrile neutropenia	12.6% 28/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	23.0% 101/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Leukopenia	10.4% 23/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	10.3% 45/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Neutropenia	15.3% 34/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	28.2% 124/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Blood and lymphatic system disorders Thrombocytopenia	26.6% 59/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	37.1% 163/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Abdominal pain	11.7% 26/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	10.7% 47/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Abdominal pain upper	6.3% 14/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.8% 30/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Constipation	24.8% 55/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	27.8% 122/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Diarrhoea	22.1% 49/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	26.4% 116/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Nausea	35.6% 79/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	28.0% 123/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Stomatitis	5.9% 13/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	17.1% 75/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Vomiting	12.2% 27/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	16.2% 71/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Asthenia	18.9% 42/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	14.6% 64/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Chest pain	3.6% 8/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.0% 22/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Chills	5.4% 12/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.9% 26/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Fatigue	13.1% 29/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	14.1% 62/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Mucosal inflammation	5.0% 11/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	14.4% 63/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Oedema	5.9% 13/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	8.2% 36/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Oedema peripheral	18.9% 42/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	17.1% 75/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Pain	4.5% 10/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	7.1% 31/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
General disorders Pyrexia	26.1% 58/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	19.4% 85/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Oral candidiasis	2.3% 5/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.7% 25/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Oral herpes	4.5% 10/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	7.1% 31/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Pneumonia	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	8.7% 38/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Urinary tract infection	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.5% 24/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Injury, poisoning and procedural complications Fall	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.9% 26/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Alanine aminotransferase increased	7.2% 16/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.9% 26/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Aspartate aminotransferase increased	6.3% 14/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	4.3% 19/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Electrocardiogram QT prolonged	3.6% 8/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	7.3% 32/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Investigations Weight decreased	9.0% 20/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	8.9% 39/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Decreased appetite	19.4% 43/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	18.7% 82/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hyperuricaemia	5.9% 13/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	3.0% 13/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypoalbuminaemia	6.3% 14/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.5% 24/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypokalaemia	16.7% 37/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	27.3% 120/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 13/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.2% 23/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Arthralgia	13.5% 30/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	10.3% 45/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Back pain	8.1% 18/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	11.4% 50/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 12/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.8% 30/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Dizziness	8.1% 18/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	9.8% 43/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Nervous system disorders Headache	10.4% 23/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	10.9% 48/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Psychiatric disorders Insomnia	9.5% 21/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	8.7% 38/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 21/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	21.6% 95/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.5% 30/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	17.3% 76/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.6% 28/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	16.2% 71/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.4% 28/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 17/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	3.9% 17/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Alopecia	1.8% 4/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.8% 30/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Petechiae	10.8% 24/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	16.6% 73/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Pruritus	7.7% 17/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	6.2% 27/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Skin and subcutaneous tissue disorders Rash	13.5% 30/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	16.4% 72/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Haematoma	9.0% 20/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	12.5% 55/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypertension	3.2% 7/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	7.1% 31/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Vascular disorders Hypotension	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.2% 23/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Gastrointestinal disorders Dyspepsia	4.1% 9/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.0% 22/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Infections and infestations Nasopharyngitis	5.9% 13/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	4.1% 18/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Metabolism and nutrition disorders Hypophosphataemia	2.7% 6/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.0% 22/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.
Psychiatric disorders Confusional state	3.2% 7/222 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.	5.0% 22/439 • From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months. The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.

Additional Information

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