Trial Outcomes & Findings for A Safety and Efficacy Study of Eltrombopag in Subjects With AML (NCT NCT01890746)

NCT ID: NCT01890746

Last Updated: 2019-09-11

Results Overview

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 148 participants
• Primary outcome timeframe: From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice
• Results posted on: 2019-09-11

Participant Flow

Participants (Par.) diagnosed with Acute Myelogenous Leukemia (AML) of any subtype (except acute promyelocytic [M3] or acute megakaryocytic leukaemia [M7]) were eligible for the study.

Sufficient number of participants were screened and 148 participants were randomized and entered in to the study. Participants were stratified by antecedent malignant hematologic disorder (yes versus no) and age (18-60 years versus >60 years), before they were randomized to receive study treatments.

Participant milestones

Measure	Eltrombopag (ELQ) QD Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Study STARTED	74	74
Overall Study COMPLETED	22	33
Overall Study NOT COMPLETED	52	41

Reasons for withdrawal

Measure	Eltrombopag (ELQ) QD Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Study Death	39	30
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	3	2
Overall Study Withdrawal by Subject	5	8

Baseline Characteristics

The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.

Baseline characteristics by cohort

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.	Total n=148 Participants Total of all reporting groups
Age, Continuous	56.7 Years STANDARD_DEVIATION 12.25 • n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	56.6 Years STANDARD_DEVIATION 11.58 • n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	56.7 Years STANDARD_DEVIATION 11.88 • n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Sex: Female, Male Female	38 Participants n=5 Participants	31 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	43 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	2 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	3 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	1 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	1 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Race/Ethnicity, Customized Asian - East Asian Heritage	26 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	17 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	43 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	1 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	1 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Race/Ethnicity, Customized White - Arabic/North African Heritage	5 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	3 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	8 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	42 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	50 Participants n=7 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.	92 Participants n=5 Participants • The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered.

PRIMARY outcome

Timeframe: From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice

Population: Safety population: all subjects who received at least one dose of investigational product.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability. Any AE	72 Participants	66 Participants
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability. Any SAE	24 Participants	14 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.

LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Change From Baseline in the Left Ventricular Ejection Fraction (LVEF). chnge from baseline (BL) to end of study	-2.5 LVEF percent Standard Deviation 7.81	-4.3 LVEF percent Standard Deviation 8.54
Change From Baseline in the Left Ventricular Ejection Fraction (LVEF). change from BL to worse post-BL case	-4.1 LVEF percent Standard Deviation 8.61	-5.7 LVEF percent Standard Deviation 9.05

PRIMARY outcome

Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population

The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Hemoglobin Low, G3	53 Participants	46 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Leukocytes, G3	10 Participants	10 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Leukocytes, G4	9 Participants	5 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Lymphocytes Low, G3	31 Participants	26 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Lymphocytes Low, G4	35 Participants	38 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Neutrophils, G4	44 Participants	39 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Platelets, G3	1 Participants	0 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters Platelets, G4	63 Participants	56 Participants

PRIMARY outcome

Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population

The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Alanine Aminotransferase, G3	1 Participants	5 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Albumin, G3	6 Participants	4 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Aspartate Aminotransferase, G3	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Bilirubin, G3	1 Participants	4 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Bilirubin, G4	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Calcium Low, G3	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Creatinine, G3	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Creatinine, G4	1 Participants	0 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Glucose High, G3	6 Participants	3 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Glucose High, G4	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Magnesium Low, G3	0 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Magnesium High, G3	3 Participants	0 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Phosphate, G3	10 Participants	19 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Phosphate, G4	1 Participants	0 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Potassium Low, G3	8 Participants	10 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Potassium Low, G4	0 Participants	2 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Potassium High, G3	4 Participants	0 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Potassium High, G4	1 Participants	1 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Sodium Low, G3	3 Participants	4 Participants
Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters Urate, G4	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety population

The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Liver Events.	2 Participants	6 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population

The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values Normal	34 Participants	33 Participants
Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values Abnormal - NCS	23 Participants	29 Participants
Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values Abnormal - CS	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Participants in the Safety Population who provided Baseline and post-Baseline assessments.

The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status Deteriorated	36 Participants	36 Participants
Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status Improved	0 Participants	1 Participants
Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status No Change	37 Participants	34 Participants

PRIMARY outcome

Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)

The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Worst-case Change From Baseline in Pulse Rate Values High	18.48 Beats/minute Standard Deviation 20.616	17.73 Beats/minute Standard Deviation 15.112
Worst-case Change From Baseline in Pulse Rate Values Low	-10.36 Beats/minute Standard Deviation 14.039	-11.24 Beats/minute Standard Deviation 12.123

PRIMARY outcome

Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population

The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Worst-case Post Baseline Change in Blood Pressure Values From Baseline SBP	14.59 millimeter of mercury (mmHg) Standard Deviation 17.936	14.34 millimeter of mercury (mmHg) Standard Deviation 14.626
Worst-case Post Baseline Change in Blood Pressure Values From Baseline DBP	9.38 millimeter of mercury (mmHg) Standard Deviation 12.000	12.61 millimeter of mercury (mmHg) Standard Deviation 10.947

PRIMARY outcome

Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).

The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Worst-case Post Baseline Change in Temperature Values From Baseline High	0.62 Degrees Celsius Standard Deviation 0.941	0.77 Degrees Celsius Standard Deviation 0.879
Worst-case Post Baseline Change in Temperature Values From Baseline Low	-0.44 Degrees Celsius Standard Deviation 0.628	-0.63 Degrees Celsius Standard Deviation 0.592

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin half-life. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Plasma Pharmacokinetics (PK) Parameter of Daunorubicin: Half-life (t1/2)	15.754 hour (h) Interval 13.969 to 17.766	13.709 hour (h) Interval 12.103 to 15.527

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicinol half-life. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Plasma Pharmacokinetics (PK) Parameter of Daunorubicinol: Half-life (t1/2)	22.735 hour (h) Interval 21.187 to 24.396	21.603 hour (h) Interval 20.232 to 23.067

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin AUC(0-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicin Dose-normalized Plasma: AUC(0-∞)	8.0807 (h*ug/ml)/(mg/m2) Interval 7.0672 to 9.2396	8.7880 (h*ug/ml)/(mg/m2) Interval 7.3893 to 10.451

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicinol AUC(0-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicinol Dose-normalized Plasma: AUC(0-∞)	63.997 (h*ug/ml)/(mg/m2) Interval 58.686 to 69.746	62.835 (h*ug/ml)/(mg/m2) Interval 58.673 to 67.292

SECONDARY outcome

Timeframe: Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin AUC(24-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicin Dose-normalized Plasma: AUC(24-∞)	0.87496 (h*ug/ml)/(mg/m2) Interval 0.76202 to 1.0046	0.72315 (h*ug/ml)/(mg/m2) Interval 0.62633 to 0.83493

SECONDARY outcome

Timeframe: Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicinol AUC(24-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicinol Dose-normalized Plasma: AUC(24-∞)	24.537 (h*ug/ml)/(mg/m2) Interval 22.052 to 27.301	23.039 (h*ug/ml)/(mg/m2) Interval 21.169 to 25.074

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin AUC(0-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicin Dose-normalized Plasma: AUC(0-t)	7.9523 (h*ug/ml)/(mg/m2) Interval 6.9485 to 9.1012	8.6723 (h*ug/ml)/(mg/m2) Interval 7.2855 to 10.323

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

daunorubicinol AUC(0-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicinol Dose-normalized Plasma: AUC(0-t)	62.463 (h*ug/ml)/(mg/m2) Interval 57.268 to 68.129	61.608 (h*ug/ml)/(mg/m2) Interval 57.5 to 66.009

SECONDARY outcome

Timeframe: Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin AUC(24-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicin Dose-normalized Plasma: AUC(24-t)	0.76524 (h*ug/ml)/(mg/m2) Interval 0.65947 to 0.88797	0.59660 (h*ug/ml)/(mg/m2) Interval 0.48882 to 0.72813

SECONDARY outcome

Timeframe: Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicinol AUC(24-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicinol Dose-normalized Plasma: AUC(24-t)	22.963 (h*ug/ml)/(mg/m2) Interval 20.557 to 25.651	21.821 (h*ug/ml)/(mg/m2) Interval 20.02 to 23.783

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicin Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicin Dose-normalized Plasma: Cmax	5.1527 (ug/ml)/(mg/m2) Interval 3.9561 to 6.7114	6.4113 (ug/ml)/(mg/m2) Interval 4.6773 to 8.7882

SECONDARY outcome

Timeframe: Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Daunorubicinol Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=72 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Daunorubicinol Dose-normalized Plasma: Cmax	3.5770 (ug/ml)/(mg/m2) Interval 3.0433 to 4.2044	3.3640 (ug/ml)/(mg/m2) Interval 2.8433 to 3.9799

SECONDARY outcome

Timeframe: Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Cycle 2 Daunorubicin AUC(0-24). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=10 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=12 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Cycle 2: Daunorubicin Dose-normalized Plasma: AUC(0-24)	10.315 (h*ug/ml)/(mg/m2) Interval 6.7932 to 15.662	8.1146 (h*ug/ml)/(mg/m2) Interval 6.0221 to 10.934

SECONDARY outcome

Timeframe: Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Cycle 2 Daunorubicinol AUC(0-24). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=10 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=12 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Cycle 2: Daunorubicinol Dose-normalized Plasma: AUC(0-24)	34.067 (h*ug/ml)/(mg/m2) Interval 26.479 to 43.829	30.820 (h*ug/ml)/(mg/m2) Interval 24.148 to 39.335

SECONDARY outcome

Timeframe: Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Cycle 2 Daunorubicin Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=10 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=12 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Cycle 2: Daunorubicin Dose-normalized Plasma: Cmax	11.141 (ug/ml)/(mg/m2) Interval 4.3653 to 28.432	3.8905 (ug/ml)/(mg/m2) Interval 1.2805 to 11.82

SECONDARY outcome

Timeframe: Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)

Population: PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.

Cycle 2 Daunorubicinol Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=10 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=12 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Cycle 2: Daunorubicinol Dose-normalized Plasma: Cmax	4.0200 (ug/ml)/(mg/m2) Interval 2.5302 to 6.387	1.9868 (ug/ml)/(mg/m2) Interval 1.4247 to 2.7708

SECONDARY outcome

Timeframe: Post-Base line up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

This was the average number of platelet transfusions per week within cycles.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Platelet Transfusions Per Week Within Cycles	1.5 Platelet transfusions per week Standard Deviation 1.18	1.4 Platelet transfusions per week Standard Deviation 1.22

SECONDARY outcome

Timeframe: From last dose of chemotherapy to up to end of study year 2 assessment

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Time to Platelet counts >= 20 Gi/L for 3 consecutive days, unaided by transfusions in patients with < 20 Gi/L after chemotherapy. For this endpoint, the event required platelet count to be >= 20 Gi/L for 3 consecutive days. Hematology was assessed daily during hospital stay but only weekly after hospital discharge and thus, platelet count was not always available for 3 consecutive days to confirm the achievement of platelet count recovery.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=70 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=68 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Time to Platelet Count Recovery >=20 Gi/L	NA Months N/A = Not enough participants achieved platelet recovery \>= 20 Gi/L	NA Months N/A = Not enough participants achieved platelet recovery \>= 20 Gi/L

SECONDARY outcome

Timeframe: From last dose of chemotherapy to up to end of study year 2 assessment

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Time to platelet counts >= 100 Gi/L unaided by transfusions in participants with < 100 Gi/L after chemotherapy.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=73 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Time to Platelet Recovery >=100 Gi/L	0.69 Months Interval 0.69 to 0.76	0.69 Months Interval 0.69 to 0.82

SECONDARY outcome

Timeframe: By Day 21

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Number of participants with platelet counts 20 Gi/L for 3 consecutive days, unaided by transfusions, in patients with < 20 Gi/L after chemotherapy.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=70 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=68 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants Who Achieved Platelet Count Recovery by Day 21	4 Count of participants	7 Count of participants

SECONDARY outcome

Timeframe: Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Platelet counts over time

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Summary of Platelet Counts Over Time C2D2	26.0 Gi/L Interval 3.0 to 831.0	28.5 Gi/L Interval 8.0 to 400.0
Summary of Platelet Counts Over Time C2D3	25.5 Gi/L Interval 0.0 to 730.0	29.0 Gi/L Interval 8.0 to 437.0
Summary of Platelet Counts Over Time C2D4	32.0 Gi/L Interval 2.0 to 678.0	35.5 Gi/L Interval 11.0 to 454.0
Summary of Platelet Counts Over Time C2D5	37.0 Gi/L Interval 9.0 to 516.0	22.0 Gi/L Interval 12.0 to 476.0
Summary of Platelet Counts Over Time C2D6	27.0 Gi/L Interval 4.0 to 430.0	33.0 Gi/L Interval 7.0 to 533.0
Summary of Platelet Counts Over Time C2D7	24.0 Gi/L Interval 6.0 to 295.0	28.5 Gi/L Interval 12.0 to 390.0
Summary of Platelet Counts Over Time C2D14	10.5 Gi/L Interval 3.0 to 31.0	16.0 Gi/L Interval 6.0 to 66.0
Summary of Platelet Counts Over Time C2D21	27.0 Gi/L Interval 9.0 to 86.0	38.0 Gi/L Interval 8.0 to 141.0
Summary of Platelet Counts Over Time C2D28	68.0 Gi/L Interval 48.0 to 333.0	173.0 Gi/L Interval 32.0 to 479.0
Summary of Platelet Counts Over Time C2D35	515.0 Gi/L Interval 412.0 to 618.0	272.0 Gi/L Interval 26.0 to 329.0
Summary of Platelet Counts Over Time C2D42	—	147.5 Gi/L Interval 45.0 to 250.0
Summary of Platelet Counts Over Time Baseline	51.5 Gi/L Interval 5.0 to 241.0	50.0 Gi/L Interval 9.0 to 232.0
Summary of Platelet Counts Over Time C1D1	52.0 Gi/L Interval 5.0 to 241.0	48.5 Gi/L Interval 9.0 to 232.0
Summary of Platelet Counts Over Time C1D2	43.5 Gi/L Interval 4.0 to 237.0	42.0 Gi/L Interval 5.0 to 368.0
Summary of Platelet Counts Over Time C1D3	35.5 Gi/L Interval 4.0 to 226.0	37.0 Gi/L Interval 7.0 to 220.0
Summary of Platelet Counts Over Time C1D4	36.5 Gi/L Interval 3.0 to 227.0	29.0 Gi/L Interval 5.0 to 146.0
Summary of Platelet Counts Over Time C1D5	33.0 Gi/L Interval 3.0 to 201.0	29.0 Gi/L Interval 5.0 to 146.0
Summary of Platelet Counts Over Time C1D6	32.0 Gi/L Interval 4.0 to 164.0	30.0 Gi/L Interval 6.0 to 125.0
Summary of Platelet Counts Over Time C1D7	27.0 Gi/L Interval 3.0 to 123.0	27.0 Gi/L Interval 4.0 to 102.0
Summary of Platelet Counts Over Time C1D8	24.0 Gi/L Interval 2.0 to 99.0	22.0 Gi/L Interval 4.0 to 80.0
Summary of Platelet Counts Over Time C1D9	20.5 Gi/L Interval 1.0 to 109.0	19.0 Gi/L Interval 5.0 to 59.0
Summary of Platelet Counts Over Time C1D14	16.5 Gi/L Interval 0.0 to 70.0	18.0 Gi/L Interval 1.0 to 81.0
Summary of Platelet Counts Over Time C1D21	39.0 Gi/L Interval 5.0 to 325.0	25.0 Gi/L Interval 2.0 to 232.0
Summary of Platelet Counts Over Time C1D28	484.5 Gi/L Interval 14.0 to 1590.0	121.0 Gi/L Interval 7.0 to 539.0
Summary of Platelet Counts Over Time C1D35	547.0 Gi/L Interval 15.0 to 1493.0	181.0 Gi/L Interval 10.0 to 424.0
Summary of Platelet Counts Over Time C1D42	—	304.0 Gi/L Interval 304.0 to 304.0
Summary of Platelet Counts Over Time C2D1	31.0 Gi/L Interval 12.0 to 1059.0	30.5 Gi/L Interval 10.0 to 432.0

SECONDARY outcome

Timeframe: At differnt time points from start of treatment and up to end of study year 2 assessment

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Maximum time period (in days) during which the patient did not receive any platelet transfusion

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Maximum Duration (Days) of Platelet Transfusion Independence	29.0 Days Interval 2.0 to 57.0	29.5 Days Interval 2.0 to 77.0

SECONDARY outcome

Timeframe: From start of treatment and up to end of study year 2 assessment

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Percentage of patients who achieved platelet transfusion independence ≥ 28 days.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Percentage of Patients Who Achieved Platelet Transfusion Independence ≥ 28 Days	55 Percentage of participants	53 Percentage of participants

SECONDARY outcome

Timeframe: At different time points from last dose of chemotherapy up to end of study year 2 assessment

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Time to absolute neutrophil count (ANC) >= 0.5 Gi/L for 3 consecutive days in participants with ANC < 0.5 Gi/L after chemotherapy

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=73 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Time to Neutrophil Engraftment	NA Months N/A = Not enough participants achieved ANC\>= 0.5 Gi/L	NA Months N/A = Not enough participants achieved ANC\>= 0.5 Gi/L

SECONDARY outcome

Timeframe: Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Absolute neutrophil counts over time

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Summary of Absolute Neutrophil Counts (ANC) Baseline	0.8 Gi/L Interval 0.0 to 37.0	0.5 Gi/L Interval 0.0 to 50.0
Summary of Absolute Neutrophil Counts (ANC) C1D1	0.8 Gi/L Interval 0.0 to 37.0	0.6 Gi/L Interval 0.0 to 50.0
Summary of Absolute Neutrophil Counts (ANC) C1D2	0.6 Gi/L Interval 0.0 to 41.0	0.5 Gi/L Interval 0.0 to 41.0
Summary of Absolute Neutrophil Counts (ANC) C1D3	0.6 Gi/L Interval 0.0 to 59.0	0.4 Gi/L Interval 0.0 to 26.0
Summary of Absolute Neutrophil Counts (ANC) C1D4	0.4 Gi/L Interval 0.0 to 35.0	0.2 Gi/L Interval 0.0 to 17.0
Summary of Absolute Neutrophil Counts (ANC) C1D5	0.3 Gi/L Interval 0.0 to 21.0	0.2 Gi/L Interval 0.0 to 2.0
Summary of Absolute Neutrophil Counts (ANC) C2D7	0.0 Gi/L Interval 0.0 to 1.0	0.1 Gi/L Interval 0.0 to 2.0
Summary of Absolute Neutrophil Counts (ANC) C1D6	0.2 Gi/L Interval 0.0 to 35.0	0.1 Gi/L Interval 0.0 to 1.0
Summary of Absolute Neutrophil Counts (ANC) C1D7	0.1 Gi/L Interval 0.0 to 29.0	0.1 Gi/L Interval 0.0 to 1.0
Summary of Absolute Neutrophil Counts (ANC) C1D8	0.1 Gi/L Interval 0.0 to 21.0	0.0 Gi/L Interval 0.0 to 1.0
Summary of Absolute Neutrophil Counts (ANC) C1D9	0.0 Gi/L Interval 0.0 to 7.0	0.0 Gi/L Interval 0.0 to 1.0
Summary of Absolute Neutrophil Counts (ANC) C1D14	0.0 Gi/L Interval 0.0 to 1.0	0.0 Gi/L Interval 0.0 to 0.0
Summary of Absolute Neutrophil Counts (ANC) C1D21	0.6 Gi/L Interval 0.0 to 18.0	0.3 Gi/L Interval 0.0 to 7.0
Summary of Absolute Neutrophil Counts (ANC) C1D28	4.3 Gi/L Interval 0.0 to 47.0	2.7 Gi/L Interval 0.0 to 25.0
Summary of Absolute Neutrophil Counts (ANC) C1D35	2.2 Gi/L Interval 0.0 to 56.0	1.7 Gi/L Interval 0.0 to 12.0
Summary of Absolute Neutrophil Counts (ANC) C1D42	—	3.1 Gi/L Interval 3.1 to 3.1
Summary of Absolute Neutrophil Counts (ANC) C2D1	0.1 Gi/L Interval 0.0 to 7.0	0.0 Gi/L Interval 0.0 to 5.0
Summary of Absolute Neutrophil Counts (ANC) C2D2	0.1 Gi/L Interval 0.0 to 3.0	0.2 Gi/L Interval 0.0 to 4.0
Summary of Absolute Neutrophil Counts (ANC) C2D3	0.2 Gi/L Interval 0.0 to 5.0	0.5 Gi/L Interval 0.0 to 4.0
Summary of Absolute Neutrophil Counts (ANC) C2D4	0.3 Gi/L Interval 0.0 to 3.0	0.5 Gi/L Interval 0.0 to 2.0
Summary of Absolute Neutrophil Counts (ANC) C2D5	0.2 Gi/L Interval 0.0 to 2.0	0.1 Gi/L Interval 0.0 to 3.0
Summary of Absolute Neutrophil Counts (ANC) C2D6	0.1 Gi/L Interval 0.0 to 1.0	0.1 Gi/L Interval 0.0 to 3.0
Summary of Absolute Neutrophil Counts (ANC) C2D14	0.0 Gi/L Interval 0.0 to 0.0	0.0 Gi/L Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Hemoglobin level over time

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Summary of Hemoglobin C1D7	85.0 g/L Interval 58.0 to 116.0	83.0 g/L Interval 57.0 to 110.0
Summary of Hemoglobin Baseline	87.6 g/L Interval 63.0 to 123.0	87.0 g/L Interval 67.0 to 121.0
Summary of Hemoglobin C1D1	88.0 g/L Interval 67.0 to 123.0	86.0 g/L Interval 67.0 to 121.0
Summary of Hemoglobin C1D2	88.0 g/L Interval 58.0 to 124.0	83.0 g/L Interval 62.0 to 130.0
Summary of Hemoglobin C1D3	86.0 g/L Interval 52.0 to 108.0	82.0 g/L Interval 59.0 to 130.0
Summary of Hemoglobin C1D4	83.0 g/L Interval 60.0 to 105.0	81.5 g/L Interval 46.0 to 120.0
Summary of Hemoglobin C1D5	84.0 g/L Interval 60.0 to 114.0	83.0 g/L Interval 50.0 to 126.0
Summary of Hemoglobin C1D6	86.0 g/L Interval 67.0 to 118.0	82.0 g/L Interval 52.0 to 119.0
Summary of Hemoglobin C1D8	85.3 g/L Interval 65.0 to 118.0	84.0 g/L Interval 57.0 to 108.0
Summary of Hemoglobin C1D9	84.5 g/L Interval 64.0 to 114.0	81.5 g/L Interval 62.0 to 109.0
Summary of Hemoglobin C1D14	85.0 g/L Interval 60.0 to 123.0	84.0 g/L Interval 59.0 to 109.0
Summary of Hemoglobin C1D21	88.0 g/L Interval 77.0 to 117.0	88.0 g/L Interval 72.0 to 116.0
Summary of Hemoglobin C1D28	99.0 g/L Interval 78.0 to 138.0	98.0 g/L Interval 79.0 to 125.0
Summary of Hemoglobin C1D35	99.0 g/L Interval 81.0 to 131.0	94.0 g/L Interval 74.0 to 130.0
Summary of Hemoglobin C1D42	—	98.0 g/L Interval 98.0 to 98.0
Summary of Hemoglobin C2D1	94.5 g/L Interval 76.0 to 124.0	82.5 g/L Interval 72.0 to 111.0
Summary of Hemoglobin C2D2	88.5 g/L Interval 72.0 to 112.0	86.5 g/L Interval 69.0 to 104.0
Summary of Hemoglobin C2D3	86.5 g/L Interval 65.0 to 110.0	80.0 g/L Interval 68.0 to 97.0
Summary of Hemoglobin C2D4	89.0 g/L Interval 72.0 to 106.0	86.5 g/L Interval 74.0 to 109.0
Summary of Hemoglobin C2D5	88.0 g/L Interval 67.0 to 101.0	84.0 g/L Interval 72.0 to 93.0
Summary of Hemoglobin C2D6	84.0 g/L Interval 68.0 to 102.0	85.0 g/L Interval 70.0 to 96.0
Summary of Hemoglobin C2D7	84.5 g/L Interval 66.0 to 99.0	83.0 g/L Interval 57.0 to 97.0
Summary of Hemoglobin C2D14	77.5 g/L Interval 66.0 to 101.0	87.0 g/L Interval 79.0 to 96.0
Summary of Hemoglobin C2D21	86.0 g/L Interval 43.0 to 99.0	91.0 g/L Interval 74.0 to 110.0
Summary of Hemoglobin C2D28	89.0 g/L Interval 80.0 to 92.0	80.0 g/L Interval 72.0 to 114.0
Summary of Hemoglobin C2D35	104.0 g/L Interval 101.0 to 107.0	87.0 g/L Interval 85.0 to 119.0
Summary of Hemoglobin C2D42	—	90.5 g/L Interval 86.0 to 95.0

SECONDARY outcome

Timeframe: Baseline, weekly within induction and re-induction cycles, end of therapy

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Incidence of bleeding events using WHO bleeding grade (G0=No bleeding, G1=Petechiae, G2=Mild blood loss, G3=Gross blood loss, G4=Debilitating blood loss) by week and cycle

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Incidence of Hemorrhagic Events Remission visit GRADE 1	2 Participants	4 Participants
Incidence of Hemorrhagic Events C1D7 - GRADE 0	58 Participants	47 Participants
Incidence of Hemorrhagic Events C1D7 - GRADE 1	9 Participants	16 Participants
Incidence of Hemorrhagic Events C1D7 - GRADE 2	5 Participants	6 Participants
Incidence of Hemorrhagic Events C1D7 - GRADE 3	1 Participants	0 Participants
Incidence of Hemorrhagic Events C1D14 - GRADE 0	42 Participants	43 Participants
Incidence of Hemorrhagic Events C1D14 - GRADE 1	16 Participants	13 Participants
Incidence of Hemorrhagic Events C1D14 - GRADE 2	5 Participants	6 Participants
Incidence of Hemorrhagic Events C1D14 - GRADE 3	1 Participants	0 Participants
Incidence of Hemorrhagic Events C1D21 - GRADE 0	36 Participants	43 Participants
Incidence of Hemorrhagic Events C1D21 - GRADE 1	13 Participants	7 Participants
Incidence of Hemorrhagic Events C1D21 - GRADE 2	3 Participants	1 Participants
Incidence of Hemorrhagic Events C1D21 - GRADE 3	0 Participants	1 Participants
Incidence of Hemorrhagic Events C1D28 - GRADE 0	31 Participants	25 Participants
Incidence of Hemorrhagic Events C1D28 - GRADE 1	4 Participants	3 Participants
Incidence of Hemorrhagic Events C1D28 - GRADE 2	2 Participants	0 Participants
Incidence of Hemorrhagic Events C1D28 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C1D35 - GRADE 0	12 Participants	11 Participants
Incidence of Hemorrhagic Events C1D35 - GRADE 1	2 Participants	2 Participants
Incidence of Hemorrhagic Events C1D35 - GRADE 2	0 Participants	0 Participants
Incidence of Hemorrhagic Events C1D35 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C1D42 - GRADE 0	—	0 Participants
Incidence of Hemorrhagic Events C1D42 - GRADE 1	—	1 Participants
Incidence of Hemorrhagic Events C1D42 - GRADE 2	—	0 Participants
Incidence of Hemorrhagic Events C1D42 - GRADE 3	—	0 Participants
Incidence of Hemorrhagic Events C2D1 - GRADE 0	8 Participants	8 Participants
Incidence of Hemorrhagic Events C2D1 - GRADE 1	1 Participants	4 Participants
Incidence of Hemorrhagic Events C2D1 - GRADE 2	1 Participants	0 Participants
Incidence of Hemorrhagic Events C2D1 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D7 - GRADE 0	9 Participants	8 Participants
Incidence of Hemorrhagic Events C2D7 - GRADE 1	0 Participants	3 Participants
Incidence of Hemorrhagic Events C2D7 - GRADE 2	1 Participants	0 Participants
Incidence of Hemorrhagic Events C2D7 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D14 - GRADE 0	8 Participants	7 Participants
Incidence of Hemorrhagic Events C2D14 - GRADE 1	0 Participants	3 Participants
Incidence of Hemorrhagic Events C2D14 - GRADE 2	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D14 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D21 - GRADE 0	7 Participants	7 Participants
Incidence of Hemorrhagic Events C2D21 - GRADE 1	1 Participants	2 Participants
Incidence of Hemorrhagic Events C2D21 - GRADE 2	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D21 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D28 - GRADE 0	5 Participants	7 Participants
Incidence of Hemorrhagic Events C2D28 - GRADE 1	0 Participants	1 Participants
Incidence of Hemorrhagic Events C2D28 - GRADE 2	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D28 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D35 - GRADE 0	3 Participants	2 Participants
Incidence of Hemorrhagic Events C2D35 - GRADE 1	0 Participants	1 Participants
Incidence of Hemorrhagic Events C2D35 - GRADE 2	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D35 - GRADE 3	0 Participants	0 Participants
Incidence of Hemorrhagic Events C2D42 - GRADE 0	—	0 Participants
Incidence of Hemorrhagic Events C2D42 - GRADE 1	—	1 Participants
Incidence of Hemorrhagic Events C2D42 - GRADE 2	—	0 Participants
Incidence of Hemorrhagic Events C2D42 - GRADE 3	—	0 Participants
Incidence of Hemorrhagic Events Remission visit GRADE 0	56 Participants	58 Participants
Incidence of Hemorrhagic Events Remission visit GRADE 2	3 Participants	0 Participants
Incidence of Hemorrhagic Events Remission visit GRADE 3	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 42 of the latest chemotherapy cycle (Up to 8 weeks)

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Disease response as assessed by the investigator using the AML International Working Group Response Assessment at the end of therapy/remission assessment visit; Complete remission (CR): defined as transfusion independence, blood count recovery (Abs. neutrophil count > 1.0 Gi/L and Platelet count > 100.0 Gi/L), no leukemic blast in peripheral blood, Bone Marrow (BM) blasts < 5%, maturation of all cell lines, Auer rods not detectable, and no extramedullary disease.

Partial remission (PR): defined as CR except that for BM blasts where a decrease of at least 50% of BM blasts to 5-25% in BM aspirate is sufficient or BM blasts < 5% with Auer rods present.

Overall response (OR) = CR + PR.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Percentage of Participants With Disease Response Rate and Type of Response Overall response	70 Percentage of participants	73 Percentage of participants
Percentage of Participants With Disease Response Rate and Type of Response Complete Remission (CR)	65 Percentage of participants	70 Percentage of participants
Percentage of Participants With Disease Response Rate and Type of Response Partial Remission (PR)	5 Percentage of participants	3 Percentage of participants

SECONDARY outcome

Timeframe: From randomization to end of 2-year follow-up

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Overall survival defined as the time form randomization until the date of death due to any cause.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Survival (OS)	39 Count of participants	30 Count of participants

SECONDARY outcome

Timeframe: At screening and from start of treatment to end of therapy/remission assessment visit (Day 42 of the latest chemotherapy cycle)

Population: The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.

Medical Resource Utilization pertained to unscheduled hospitalizations, unscheduled office visits, unscheduled laboratory tests, and unscheduled procedures.

Outcome measures

Measure	Eltrombopag (ELQ) QD n=74 Participants Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=74 Participants Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Number of Participants Who Required Medical Resource Utilization In-patient hospitalizations/ admissions?	3 Count of participants	4 Count of participants
Number of Participants Who Required Medical Resource Utilization Diagnostic imaging procedures performed?	3 Count of participants	4 Count of participants
Number of Participants Who Required Medical Resource Utilization Health care resources use or emergency visits?	8 Count of participants	6 Count of participants
Number of Participants Who Required Medical Resource Utilization Out-patient lab tests performed?	6 Count of participants	6 Count of participants

Adverse Events

Eltrombopag (ELQ) QD

Serious events: 24 serious events

Other events: 71 other events

Deaths: 11 deaths

Placebo QD

Serious events: 14 serious events

Other events: 66 other events

Deaths: 4 deaths

Serious adverse events

Measure	Eltrombopag (ELQ) QD n=74 participants at risk Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 participants at risk Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Atrial fibrillation	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Cardiac failure	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Cardiac failure congestive	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Cardiomyopathy	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Left ventricular dysfunction	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Myocardial infarction	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Congenital, familial and genetic disorders Hydrocele	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal pain	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Constipation	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Neutropenic colitis	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Generalised oedema	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Pyrexia	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Sudden death	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Acinetobacter bacteraemia	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Appendicitis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Bronchitis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Catheter site infection	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Klebsiella sepsis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Neutropenic sepsis	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Perirectal abscess	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Pneumonia	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Sepsis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Septic shock	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Systemic candida	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Alanine aminotransferase increased	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Blood bilirubin increased	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Ejection fraction decreased	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Pseudohyperkalaemia	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Cerebral haemorrhage	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Cerebrovascular accident	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Cognitive disorder	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Haemorrhage intracranial	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Renal and urinary disorders Acute kidney injury	4.1% 3/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Renal and urinary disorders Renal failure	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)

Other adverse events

Measure	Eltrombopag (ELQ) QD n=74 participants at risk Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m\^2 for Par. 18-60 years old or 60 mg/m\^2 for Par.\>60 years old plus cytarabine 100 mg/m\^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not \>100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m\^2/day on D1-3 plus cytarabine 100 mg/m\^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.	Placebo QD n=71 participants at risk Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m\^2 for participants 18-60 years old or 60 mg/m\^2 for participants \>60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m\^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Blood and lymphatic system disorders Anaemia	9.5% 7/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	9.9% 7/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Blood and lymphatic system disorders Febrile neutropenia	51.4% 38/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	59.2% 42/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Blood and lymphatic system disorders Neutropenia	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Blood and lymphatic system disorders Thrombocytopenia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Blood and lymphatic system disorders Thrombocytosis	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Cardiac disorders Sinus tachycardia	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal discomfort	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal distension	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal pain	24.3% 18/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	23.9% 17/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Abdominal pain upper	4.1% 3/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	16.9% 12/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Constipation	37.8% 28/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	29.6% 21/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Diarrhoea	56.8% 42/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	60.6% 43/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Dry mouth	9.5% 7/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Dyspepsia	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	12.7% 9/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Gastrooesophageal reflux disease	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Gingival bleeding	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Gingival pain	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	4.2% 3/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Gingival swelling	4.1% 3/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Haemorrhoids	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	12.7% 9/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Lip dry	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Mouth haemorrhage	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	0.00% 0/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Mouth ulceration	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Nausea	50.0% 37/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	64.8% 46/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Proctalgia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	14.1% 10/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Stomatitis	25.7% 19/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	25.4% 18/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Gastrointestinal disorders Vomiting	36.5% 27/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	38.0% 27/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Asthenia	17.6% 13/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	18.3% 13/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Catheter site haemorrhage	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Chest pain	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Chills	28.4% 21/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	19.7% 14/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Fatigue	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	15.5% 11/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Mucosal inflammation	12.2% 9/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	12.7% 9/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Oedema	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Oedema peripheral	16.2% 12/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	18.3% 13/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Pain	4.1% 3/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
General disorders Pyrexia	33.8% 25/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	23.9% 17/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Bacteraemia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Cellulitis	0.00% 0/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Device related infection	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	12.7% 9/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Oral candidiasis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Pneumonia	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	4.2% 3/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Infections and infestations Sepsis	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	4.2% 3/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Injury, poisoning and procedural complications Procedural pain	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Injury, poisoning and procedural complications Transfusion reaction	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Alanine aminotransferase increased	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	19.7% 14/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Aspartate aminotransferase increased	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Blood bilirubin increased	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Neutrophil count decreased	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Platelet count decreased	9.5% 7/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Serum ferritin increased	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations Weight increased	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Investigations White blood cell count decreased	12.2% 9/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Decreased appetite	29.7% 22/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	38.0% 27/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Fluid imbalance	16.2% 12/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	14.1% 10/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Fluid overload	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hyperkalaemia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypoalbuminaemia	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypocalcaemia	9.5% 7/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	14.1% 10/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypokalaemia	27.0% 20/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	38.0% 27/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypomagnesaemia	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	18.3% 13/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hyponatraemia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Hypophosphataemia	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	19.7% 14/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Metabolism and nutrition disorders Iron overload	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	4.2% 3/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	4.2% 3/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Musculoskeletal and connective tissue disorders Back pain	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	21.1% 15/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Musculoskeletal and connective tissue disorders Pain in extremity	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Dizziness	14.9% 11/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Nervous system disorders Headache	25.7% 19/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	28.2% 20/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Psychiatric disorders Anxiety	13.5% 10/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	9.9% 7/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Psychiatric disorders Insomnia	21.6% 16/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	32.4% 23/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Renal and urinary disorders Haematuria	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Renal and urinary disorders Urinary hesitation	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	1.4% 1/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Atelectasis	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Cough	24.3% 18/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	25.4% 18/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	15.5% 11/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Epistaxis	24.3% 18/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	19.7% 14/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Haemoptysis	9.5% 7/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Hiccups	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Nasal dryness	4.1% 3/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	17.6% 13/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	18.3% 13/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.7% 2/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Productive cough	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Alopecia	1.4% 1/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Erythema	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	7.0% 5/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Hyperhidrosis	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	2.8% 2/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Petechiae	16.2% 12/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	14.1% 10/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Pruritus	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Rash	29.7% 22/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	18.3% 13/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Rash maculo-papular	10.8% 8/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Skin and subcutaneous tissue disorders Urticaria	5.4% 4/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	5.6% 4/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Vascular disorders Hypertension	8.1% 6/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	11.3% 8/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)
Vascular disorders Hypotension	6.8% 5/74 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)	8.5% 6/71 • Adverse events and serious adverse events were collected from Day 1 of cycle 1 until last dose of investigational product + 30 days i.e. a maximum of 114 days (42 days for the induction cycle + 42 days for the re-induction cycle + 30 days for the follow-up)

Additional Information

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Results disclosure agreements

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