Trial Outcomes & Findings for A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia (NCT NCT01292603)
NCT ID: NCT01292603
Last Updated: 2018-12-19
Results Overview
Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m\^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
240 participants
Primary outcome timeframe
Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose
Results posted on
2018-12-19
Participant Flow
In Part 1 a single dose of subcutaneous (SC) rituximab was administered at Cycle 6 to select a dose resulting in trough concentration (Ctrough) non-inferior to intravenous (IV) dose. In Part 2, participants were randomized to receive rituximab IV or SC, to demonstrate non-inferiority of rituximab Ctrough levels of SC dose compared with IV dose.
Participant milestones
| Measure |
Part 1: Rituximab SC 1400 Milligrams (mg)
Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 milligrams per square meter (mg/m\^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1600 mg
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
|---|---|---|---|---|---|---|
|
Part 1: Pilot Dose Selection Period
STARTED
|
16
|
17
|
23
|
8
|
0
|
0
|
|
Part 1: Pilot Dose Selection Period
COMPLETED
|
16
|
17
|
23
|
0
|
0
|
0
|
|
Part 1: Pilot Dose Selection Period
NOT COMPLETED
|
0
|
0
|
0
|
8
|
0
|
0
|
|
Part 1: Regular Follow-Up Period
STARTED
|
16
|
17
|
23
|
8
|
0
|
0
|
|
Part 1: Regular Follow-Up Period
COMPLETED
|
10
|
10
|
17
|
7
|
0
|
0
|
|
Part 1: Regular Follow-Up Period
NOT COMPLETED
|
6
|
7
|
6
|
1
|
0
|
0
|
|
Part 2: Dose Confirmation Period
STARTED
|
0
|
0
|
0
|
0
|
88
|
88
|
|
Part 2: Dose Confirmation Period
COMPLETED
|
0
|
0
|
0
|
0
|
72
|
73
|
|
Part 2: Dose Confirmation Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
16
|
15
|
|
Part 2: Regular Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
87
|
87
|
|
Part 2: Regular Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
68
|
75
|
|
Part 2: Regular Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
19
|
12
|
|
Overall Survival Status
STARTED
|
16
|
17
|
23
|
8
|
88
|
88
|
|
Overall Survival Status
COMPLETED
|
13
|
16
|
20
|
7
|
72
|
78
|
|
Overall Survival Status
NOT COMPLETED
|
3
|
1
|
3
|
1
|
16
|
10
|
Reasons for withdrawal
| Measure |
Part 1: Rituximab SC 1400 Milligrams (mg)
Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 milligrams per square meter (mg/m\^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1600 mg
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
|---|---|---|---|---|---|---|
|
Part 1: Pilot Dose Selection Period
Adverse Event
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Part 1: Pilot Dose Selection Period
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Pilot Dose Selection Period
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 1: Pilot Dose Selection Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Regular Follow-Up Period
Death
|
3
|
1
|
3
|
1
|
0
|
0
|
|
Part 1: Regular Follow-Up Period
Disease Progression
|
3
|
6
|
3
|
0
|
0
|
0
|
|
Part 2: Dose Confirmation Period
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2: Dose Confirmation Period
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part 2: Dose Confirmation Period
Withdrawn Prior to Treatment
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part 2: Dose Confirmation Period
Adverse Event
|
0
|
0
|
0
|
0
|
7
|
9
|
|
Part 2: Dose Confirmation Period
Protocol Violation
|
0
|
0
|
0
|
0
|
5
|
3
|
|
Part 2: Dose Confirmation Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2: Regular Follow-Up
Death
|
0
|
0
|
0
|
0
|
6
|
3
|
|
Part 2: Regular Follow-Up
Disease Progression
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Part 2: Regular Follow-Up
Noncompliance
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2: Regular Follow-Up
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Regular Follow-Up
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part 2: Regular Follow-Up
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part 2: Regular Follow-Up
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part 2: Regular Follow-Up
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Overall Survival Status
Death
|
3
|
1
|
3
|
1
|
16
|
10
|
Baseline Characteristics
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Part 1: Rituximab SC 1400 Milligrams (mg)
n=16 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1600 mg
n=17 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=22 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2 : Rituximab IV 500 mg/m^2
n=89 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 8.18 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 9.03 • n=4 Participants
|
59.1 years
STANDARD_DEVIATION 8.87 • n=21 Participants
|
58.8 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
153 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dosePopulation: Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.
Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m\^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=56 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab
|
1600 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: +/- 25hours around the 28th day post the 5th Cycle of Rituximab administrationPopulation: Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.
Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=69 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=65 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Rituximab C Trough Levels at Cycle 5
|
61.50 μg/mL
Geometric Coefficient of Variation 89.54
|
97.53 μg/mL
Geometric Coefficient of Variation 55.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6Population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).
Outcome measures
| Measure |
Part 1: Rituximab SC
n=58 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=51 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6
|
3630.43 μg*day/mL
Geometric Coefficient of Variation 38.61
|
4088.78 μg*day/mL
Geometric Coefficient of Variation 37.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6Population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=58 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=51 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6
|
279.78 μg/mL
Geometric Coefficient of Variation 23.96
|
202.16 μg/mL
Geometric Coefficient of Variation 36.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6Population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=58 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=51 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6
|
0.22 days
Geometric Coefficient of Variation 130.84
|
3.14 days
Geometric Coefficient of Variation 87.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6Population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=58 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=50 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Terminal Half-Life of Rituximab at Cycle 6
|
30.09 days
Geometric Coefficient of Variation 41.86
|
30.71 days
Geometric Coefficient of Variation 33.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4 to 5 in Cycle 6Population: All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.
In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC
Outcome measures
| Measure |
Part 1: Rituximab SC
n=16 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=17 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=23 Participants
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Participants who preferred SC
|
88.0 percentage of participants or nurses
|
100.0 percentage of participants or nurses
|
91.0 percentage of participants or nurses
|
—
|
—
|
|
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Participants who preferred IV
|
13.0 percentage of participants or nurses
|
0.0 percentage of participants or nurses
|
9.0 percentage of participants or nurses
|
—
|
—
|
|
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Nurses who preferred SC
|
88.0 percentage of participants or nurses
|
100.0 percentage of participants or nurses
|
91.0 percentage of participants or nurses
|
—
|
—
|
|
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Nurses who preferred IV
|
13.0 percentage of participants or nurses
|
0.0 percentage of participants or nurses
|
9.0 percentage of participants or nurses
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4-5 in Cycle 6Population: All the physicians and nurses who responded to the questionnaire were included in the analysis.
Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=78 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=81 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Nurse: 4 or more hours
|
21.0 percentage of participants in the survey
|
21.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Nurse: At least 3 hours but less than 4 hours
|
23.0 percentage of participants in the survey
|
29.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Nurse: At least 2 hours but less than 3 hours
|
26.0 percentage of participants in the survey
|
23.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Nurse: At least 1 hour but less than 2 hours
|
17.0 percentage of participants in the survey
|
11.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Nurse: Less than 1 hour
|
13.0 percentage of participants in the survey
|
16.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Physician: 4 or more hours
|
21.0 percentage of participants in the survey
|
22.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Physician: At least 3 hours but less than 4 hours
|
18.0 percentage of participants in the survey
|
21.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Physician: At least 2 hours but less than 3 hours
|
24.0 percentage of participants in the survey
|
26.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Physician: At least 1 hour but less than 2 hours
|
22.0 percentage of participants in the survey
|
19.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Physician: Less than 1 hour
|
10.0 percentage of participants in the survey
|
7.0 percentage of participants in the survey
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4-5 in Cycle 6Population: All the physicians and nurses who responded to the questionnaire were included in the analysis.
Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=78 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=81 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Nurse: Rituximab SC is much more convenient
|
81.0 percentage of participants in the survey
|
77.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Nurse: Rituximab SC is a little more convenient
|
7.0 percentage of participants in the survey
|
9.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Nurse: Both formulations are equally convenient
|
9.0 percentage of participants in the survey
|
4.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Nurse: Rituximab IV is a little more convenient
|
3.0 percentage of participants in the survey
|
10.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Nurse: Rituximab IV is much more convenient
|
0.0 percentage of participants in the survey
|
0.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Physician: Rituximab SC is much more convenient
|
78.0 percentage of participants in the survey
|
80.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Physician: Rituximab SC a little more convenient
|
15.0 percentage of participants in the survey
|
14.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Physician: Both formulations equally convenient
|
6.0 percentage of participants in the survey
|
6.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Physician: Rituximab IV a little more convenient
|
0.0 percentage of participants in the survey
|
0.0 percentage of participants in the survey
|
—
|
—
|
—
|
|
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Physician: Rituximab IV is much more convenient
|
0.0 percentage of participants in the survey
|
0.0 percentage of participants in the survey
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dosePopulation: Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.
Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=64 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Pre-Dose Cycle 5: positive for HACAs (n=59)
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Pre-Dose Cycle 5: negative for HACAs (n=59)
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Post-Dose: positive for HACAs (n=61)
|
5.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Post-Dose: negative for HACAs (n=61)
|
95.1 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.Population: SAP; n = number of participants analyzed for the specific parameter.
In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=89 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
Baseline pre Cycle 1: positive for HACAs (n=87,85)
|
0.0 percentage of participants
|
2.4 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
Baseline pre Cycle 1: negative for HACAs (n=87,85)
|
100.0 percentage of participants
|
97.6 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
Post-Baseline: positive for HACAs (n=89,85)
|
15.0 percentage of participants
|
12.0 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
Post-Baseline: negative for HACAs (n=89,85)
|
85.0 percentage of participants
|
88.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24Population: Part 1 SAP; n = number of participants analyzed at the specified visit.
CD 19 is a surface antigen (protein) present on B-lymphocytes.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=16 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=17 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=22 Participants
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
n=1 Participants
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
n=8 Participants
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
Cycle 5 Day 1 (n=15,13,19,1,2)
|
2 cells per microliter (cells/μL)
Interval 0.0 to 157.0
|
3 cells per microliter (cells/μL)
Interval 0.0 to 419.0
|
0 cells per microliter (cells/μL)
Interval 0.0 to 19.0
|
84 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
2 cells per microliter (cells/μL)
Interval 1.0 to 2.0
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
Cycle 6 Day 1 (n=15,14,18,1,0)
|
1 cells per microliter (cells/μL)
Interval 0.0 to 90.0
|
2 cells per microliter (cells/μL)
Interval 0.0 to 22.0
|
1 cells per microliter (cells/μL)
Interval 0.0 to 5.0
|
27 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 28 Day Visit (n=15,11,19,1,0)
|
2 cells per microliter (cells/μL)
Interval 0.0 to 113.0
|
2 cells per microliter (cells/μL)
Interval 0.0 to 8.0
|
0 cells per microliter (cells/μL)
Interval 0.0 to 7.0
|
7 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 56 Day Visit (n=15,9,15,1,0)
|
1 cells per microliter (cells/μL)
Interval 0.0 to 215.0
|
3 cells per microliter (cells/μL)
Interval 1.0 to 42.0
|
0 cells per microliter (cells/μL)
Interval 0.0 to 2.0
|
14 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 3 Month Visit (n=16,8,18,0,0)
|
3 cells per microliter (cells/μL)
Interval 0.0 to 469.0
|
1 cells per microliter (cells/μL)
Interval 0.0 to 5.0
|
1 cells per microliter (cells/μL)
Interval 0.0 to 6.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 6 Month Visit (n=15,13,17,1,0)
|
2 cells per microliter (cells/μL)
Interval 0.0 to 5929.0
|
1 cells per microliter (cells/μL)
Interval 0.0 to 265.0
|
2 cells per microliter (cells/μL)
Interval 0.0 to 96.0
|
51 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 9 Month Visit (n=15,13,15,1,0)
|
66 cells per microliter (cells/μL)
Interval 0.0 to 15727.0
|
19 cells per microliter (cells/μL)
Interval 1.0 to 728.0
|
29 cells per microliter (cells/μL)
Interval 0.0 to 1153.0
|
74 cells per microliter (cells/μL)
Only 1 participant was analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 12 Month Visit (n=14,14,20,0,0)
|
126 cells per microliter (cells/μL)
Interval 4.0 to 1457.0
|
31 cells per microliter (cells/μL)
Interval 0.0 to 2775.0
|
90 cells per microliter (cells/μL)
Interval 2.0 to 1281.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 15 Month Visit (n=14,11,15,0,0)
|
175 cells per microliter (cells/μL)
Interval 14.0 to 2426.0
|
41 cells per microliter (cells/μL)
Interval 3.0 to 6588.0
|
106 cells per microliter (cells/μL)
Interval 29.0 to 500.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 18 Month Visit (n=13,14,15,0,0)
|
175 cells per microliter (cells/μL)
Interval 15.0 to 5871.0
|
82 cells per microliter (cells/μL)
Interval 16.0 to 13749.0
|
189 cells per microliter (cells/μL)
Interval 22.0 to 478.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 21 Month Visit (n=13,12,16,0,0)
|
128 cells per microliter (cells/μL)
Interval 27.0 to 10679.0
|
78 cells per microliter (cells/μL)
Interval 9.0 to 314.0
|
149 cells per microliter (cells/μL)
Interval 57.0 to 783.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
|
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
FU 24 Month Visit(n=12, 4,16,0,0)
|
238 cells per microliter (cells/μL)
Interval 29.0 to 11989.0
|
110 cells per microliter (cells/μL)
Interval 25.0 to 2225.0
|
232 cells per microliter (cells/μL)
Interval 69.0 to 1343.0
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
NA cells per microliter (cells/μL)
No participants were analyzed in this group.
|
SECONDARY outcome
Timeframe: Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24Population: Part 1 SAP; n = number of participants analyzed at the specified visit.
Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=16 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=17 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=22 Participants
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
n=1 Participants
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
n=8 Participants
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 5 Day 1 (n=15,1319,1,2)
|
93.3 percentage of participants
|
92.3 percentage of participants
|
100.0 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 6 Day 1(n= 15,14,18,1,0)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 28 Day Visit (n=15,11,19,1,0)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 56 Day Visit (n=15,9,15,1,0)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 3 Month Visit (n=16,8,18,0,0)
|
93.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 6 Month Visit (n=15,13,17,1,0)
|
86.7 percentage of participants
|
92.3 percentage of participants
|
94.1 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 9 Month Visit (n=15,13,15,1,0)
|
53.3 percentage of participants
|
84.6 percentage of participants
|
60.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 12 Month Visit (n=14,14,20,0,0)
|
28.6 percentage of participants
|
85.7 percentage of participants
|
45.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 15 Month Visit (n=14,11,15,0,0)
|
35.7 percentage of participants
|
54.5 percentage of participants
|
40.0 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 18 Month Visit (n=13,14,15,0,0)
|
30.8 percentage of participants
|
50.0 percentage of participants
|
26.7 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 21 Month Visit (n=13,12,16,0,0)
|
30.8 percentage of participants
|
50.0 percentage of participants
|
18.8 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
|
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
FU 24 Month Visit (n=12,14,16,0,0)
|
25.0 percentage of participants
|
21.4 percentage of participants
|
18.8 percentage of participants
|
NA percentage of participants
No participants were analyzed in this group.
|
NA percentage of participants
No participants were analyzed in this group.
|
SECONDARY outcome
Timeframe: Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal VisitPopulation: Part 2 SAP; n = number of participants analyzed at the specified visit.
CD 19 is a surface antigen (protein) present on B-lymphocytes.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=89 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 1 - Baseline (n=80,80)
|
68905 cells/μL
Interval 3996.0 to 277645.0
|
50565 cells/μL
Interval 640.0 to 453292.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 2 - Pre-dose (n=71,74)
|
338 cells/μL
Interval 2.0 to 38252.0
|
253 cells/μL
Interval 1.0 to 92469.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 2 - Post-dose (n=65, 66)
|
163 cells/μL
Interval 3.0 to 13026.0
|
168 cells/μL
Interval 1.0 to 32615.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 2 Day 2 (n=54, 59)
|
154 cells/μL
Interval 6.0 to 10416.0
|
266 cells/μL
Interval 0.0 to 40815.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 2 Day 3 (n=48, 54)
|
87 cells/μL
Interval 0.0 to 14769.0
|
125 cells/μL
Interval 0.0 to 13229.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 3 Day 1 (n=67,68)
|
12 cells/μL
Interval 0.0 to 13118.0
|
8 cells/μL
Interval 1.0 to 22392.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 4 Day 1 (n=71,69)
|
4 cells/μL
Interval 0.0 to 17827.0
|
4 cells/μL
Interval 0.0 to 18672.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 5 Day 1 (n=68,67)
|
2 cells/μL
Interval 0.0 to 7146.0
|
2 cells/μL
Interval 0.0 to 8542.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Cycle 6 Day 1 (n=71,64)
|
3 cells/μL
Interval 0.0 to 3612.0
|
3 cells/μL
Interval 0.0 to 4234.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 28 Day Visit (n=66,64)
|
2 cells/μL
Interval 0.0 to 1299.0
|
2 cells/μL
Interval 0.0 to 2749.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 56 Day Visit (n=63,67)
|
2 cells/μL
Interval 0.0 to 14331.0
|
2 cells/μL
Interval 0.0 to 3539.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 3 Month Visit (n=67,67)
|
2 cells/μL
Interval 0.0 to 39037.0
|
2 cells/μL
Interval 0.0 to 16413.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 6 Month Visit (n=60,69)
|
3 cells/μL
Interval 0.0 to 1356.0
|
3 cells/μL
Interval 0.0 to 22630.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 9 Month Visit (n=65,64)
|
35 cells/μL
Interval 1.0 to 3776.0
|
30 cells/μL
Interval 0.0 to 890.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 12 Month Visit (n=60,61)
|
91 cells/μL
Interval 4.0 to 9372.0
|
104 cells/μL
Interval 1.0 to 1770.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 15 Month Visit (n=59,60)
|
135 cells/μL
Interval 6.0 to 16328.0
|
171 cells/μL
Interval 5.0 to 9431.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 18 Month Visit (n=57,58)
|
134 cells/μL
Interval 5.0 to 15404.0
|
223 cells/μL
Interval 3.0 to 22363.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 21 Month Visit (n=55,52)
|
171 cells/μL
Interval 5.0 to 7901.0
|
277 cells/μL
Interval 5.0 to 39435.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
FU 24 Month Visit (n=56,51)
|
214 cells/μL
Interval 0.0 to 78010.0
|
256 cells/μL
Interval 6.0 to 10482.0
|
—
|
—
|
—
|
|
Part 2: Total CD19+ B-Cell Counts by Visit
Withdrawn/Termination (n=17,15)
|
150 cells/μL
Interval 2.0 to 90310.0
|
6 cells/μL
Interval 0.0 to 35325.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal VisitPopulation: Part 2 SAP; n= number of participants analyzed at the specified visit.
Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.
Outcome measures
| Measure |
Part 1: Rituximab SC
n=89 Participants
Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 Participants
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 12 Month Visit (n=60,61)
|
43.3 percentage of participants
|
42.6 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 15 Month Visit (n=59,60)
|
33.9 percentage of participants
|
30.0 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 1 - Baseline (n=80,80))
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 2 - Pre-dose (n=71, 74)
|
23.9 percentage of participants
|
31.1 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 2 - Post-dose (n=65, 66)
|
32.3 percentage of participants
|
37.9 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 2 Day 2 (n=54, 59)
|
35.2 percentage of participants
|
30.5 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 2 Day 3 (n=48, 54)
|
50.0 percentage of participants
|
37.0 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 3 Day 1 (n=67,68)
|
73.1 percentage of participants
|
76.5 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 4 Day 1 (n=71,69)
|
83.1 percentage of participants
|
84.1 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 5 Day 1 (n=68,67)
|
88.2 percentage of participants
|
89.6 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Cycle 6 Day 1 (n=71,64)
|
95.8 percentage of participants
|
95.3 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 28 Day Visit (n=66,64)
|
95.5 percentage of participants
|
96.9 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 56 Day Visit (n=63,67)
|
92.1 percentage of participants
|
97.0 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 3 Month Visit (n=67,67)
|
95.5 percentage of participants
|
92.5 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 6 Month Visit (n=60,69)
|
88.3 percentage of participants
|
91.3 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 9 Month Visit (n=65,64)
|
66.2 percentage of participants
|
70.3 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 18 Month Visit (n=57,58)
|
24.6 percentage of participants
|
25.9 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 21 Month Visit (n=55,52)
|
14.5 percentage of participants
|
19.2 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
FU 24 Month Visit (n=56,51)
|
10.7 percentage of participants
|
15.7 percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Withdrawn/Termination (n=17,15)
|
41.2 percentage of participants
|
73.3 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Part 1: Rituximab SC 1400 mg
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1: Rituximab SC 1600 mg
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 1: Rituximab SC 1870 mg
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Part 1: Rituximab SC 1000 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: No SC Dose Received
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 : Rituximab IV 500 mg/m^2
Serious events: 35 serious events
Other events: 80 other events
Deaths: 0 deaths
Part 2: Rituximab SC 1600 mg
Serious events: 32 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Rituximab SC 1400 mg
n=16 participants at risk
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1600 mg
n=17 participants at risk
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=22 participants at risk
PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
n=1 participants at risk
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
n=8 participants at risk
These participants were withdrawn prior to SC treatment.
|
Part 2 : Rituximab IV 500 mg/m^2
n=89 participants at risk
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 participants at risk
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
4/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.6%
9/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.4%
3/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.0%
8/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Peumonia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.4%
3/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.4%
2/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.2%
2/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Peritoneum
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.5%
3/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Death
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Cardiac disorders
Cardiac Failure
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Eye disorders
Diabetic Retinal Oedema
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Injury, poisoning and procedural complications
Wound Dehiscene
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Guillain- Barre Syndrome
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Localised Oedema
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.2%
2/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Meningitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Meningitis Cryptococcal
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Oesophageal Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Progressive Multifocal Leukoencephalopathy
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Meralgia Paraesthetica
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo- Papular
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
BARTHOLINITIS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
ANAL ULCER
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.4%
3/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
ENCEPHALITIS AUTOIMMUNE
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
Other adverse events
| Measure |
Part 1: Rituximab SC 1400 mg
n=16 participants at risk
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1600 mg
n=17 participants at risk
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1870 mg
n=22 participants at risk
PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: Rituximab SC 1000 mg
n=1 participants at risk
One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 1: No SC Dose Received
n=8 participants at risk
These participants were withdrawn prior to SC treatment.
|
Part 2 : Rituximab IV 500 mg/m^2
n=89 participants at risk
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
Part 2: Rituximab SC 1600 mg
n=85 participants at risk
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.8%
7/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
47.1%
8/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
40.9%
9/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
37.5%
3/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
57.3%
51/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
63.5%
54/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.8%
3/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
35.3%
6/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
16.9%
15/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
18.8%
16/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
25.0%
2/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
23.6%
21/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.9%
11/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
100.0%
1/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
28.1%
25/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
23.5%
20/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
35.3%
6/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
18.2%
4/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
25.0%
2/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
34.8%
31/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
37.6%
32/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
31.8%
7/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
25.0%
2/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
22.5%
20/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
21.2%
18/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
23.5%
4/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
13.6%
3/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.1%
9/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
10/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
7.9%
7/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.6%
5/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
29.4%
5/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
25.8%
23/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
30.6%
26/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Chills
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.1%
9/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
14.1%
12/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Injection site pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
13.6%
3/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
16.5%
14/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Injection site erythema
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
18.2%
4/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
25.9%
22/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Asthenia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
18.0%
16/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.4%
8/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.1%
9/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.6%
9/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Chest pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Feeling hot
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Injection site discolouration
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Injection site swelling
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
18.2%
4/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.6%
5/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.5%
3/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
6.7%
6/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.7%
4/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
13.6%
3/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
14.6%
13/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
10/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Herpes zoster
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.6%
5/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.7%
4/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
7.9%
7/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.4%
2/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.0%
8/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Laryngitis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.4%
3/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
13.6%
3/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
10.1%
9/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
15.3%
13/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
7.9%
7/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.5%
3/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
3.4%
3/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
6.7%
6/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
16.5%
14/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
4/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.4%
8/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.2%
10/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
10/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
17.6%
3/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
13.6%
3/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.2%
10/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
8.2%
7/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.6%
5/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.4%
2/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
2/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Investigations
Weight decreased
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Investigations
Serum ferritin decreased
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
6.7%
6/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Thrombophlebitis
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.1%
1/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
11.8%
10/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.2%
2/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
5/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
2.2%
2/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
5/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
6.7%
6/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
1.2%
1/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Gastrointestinal disorders
DYSCHEZIA
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
4.5%
1/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
12.5%
1/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
9.1%
2/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.9%
1/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Hot Flush
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Peripheral Venous Disease
|
6.2%
1/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/17 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/22 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/1 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/8 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
5.6%
5/89 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
0.00%
0/85 • Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER