Trial Outcomes & Findings for Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia (NCT NCT01259713)
NCT ID: NCT01259713
Last Updated: 2015-05-07
Results Overview
Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
During remission-induction chemotherapy (average 7 weeks)
Results posted on
2015-05-07
Participant Flow
Participants were enrolled at a total of 86 study sites. The first participant was screened on 13 April 2011. The last study visit occurred on 29 January 2014.
391 participants were screened.
Participant milestones
| Measure |
Liposomal Amphotericin B
Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
237
|
118
|
|
Overall Study
COMPLETED
|
142
|
77
|
|
Overall Study
NOT COMPLETED
|
95
|
41
|
Reasons for withdrawal
| Measure |
Liposomal Amphotericin B
Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
54
|
23
|
|
Overall Study
Death Not Related to IFI
|
8
|
1
|
|
Overall Study
Investigators Discretion
|
14
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Subject Withdrew Consent
|
12
|
7
|
Baseline Characteristics
Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Liposomal Amphotericin B
n=237 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=118 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 15.16 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 17.52 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 15.96 • n=5 Participants
|
|
Age, Customized
≤ 25 years
|
37 participants
n=5 Participants
|
25 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age, Customized
> 25 to ≤ 60 years
|
160 participants
n=5 Participants
|
64 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Age, Customized
> 60 years
|
40 participants
n=5 Participants
|
29 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
211 participants
n=5 Participants
|
100 participants
n=7 Participants
|
311 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
52 participants
n=5 Participants
|
23 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
41 participants
n=5 Participants
|
25 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
France
|
33 participants
n=5 Participants
|
19 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
21 participants
n=5 Participants
|
7 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: Intent-to-Treat (ITT) Analysis Set: participants in the safety analysis set who had no major violations of entrance criteria.
Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
|
7.9 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader
|
20.2 percentage of participants
|
27.0 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator
|
11.0 percentage of participants
|
10.8 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if \< 50% of participants had an event; Q1 was not reached if \< 25% of participants had an event; Q3 was not reached if \< 75% of participants had an event.
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.
|
NA days
NA = Not reached
|
NA days
NA = Not reached
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy
|
16.2 percentage of participants
|
21.6 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.
|
0.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.
|
0.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy
|
50 days
Interval 38.0 to 75.0
|
55 days
Interval 36.0 to 75.0
|
SECONDARY outcome
Timeframe: During remission-induction chemotherapy (average 7 weeks)Population: ITT Analysis Set
This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.
Outcome measures
| Measure |
Liposomal Amphotericin B
n=228 Participants
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=111 Participants
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Percentage of Participants With Complete Remission at the End of Remission Induction
|
72.8 percentage of participants
|
79.3 percentage of participants
|
Adverse Events
Liposomal Amphotericin B
Serious events: 79 serious events
Other events: 233 other events
Deaths: 0 deaths
Placebo
Serious events: 38 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liposomal Amphotericin B
n=237 participants at risk
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=118 participants at risk
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
10/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
4/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Colitis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Caecitis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Ileus
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Pyrexia
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
2.5%
3/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Chestpain
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Chills
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Inflammation
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Mucosal inflammation
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Multi-organ failure
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Liver disorder
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Immune system disorders
Allergic oedema
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Immune system disorders
Drug hypersensitivity
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Immune system disorders
Hypersensitivity
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Septic shock
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumonia
|
3.0%
7/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
2.5%
3/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Sepsis
|
1.7%
4/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Device related infection
|
1.3%
3/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Bacterial sepsis
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumonia bacterial
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Respiratory moniliasis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Staphylococcal infection
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Streptococcal sepsis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Blood creatinine increased
|
1.3%
3/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Creatinine renal clearance decreased
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Lymphocyte count decreased
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
White blood cell count decreased
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone marrow
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Encephalopathy
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Encephalitis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Meningism
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
4/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
3/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
1.7%
2/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Hypotension
|
0.42%
1/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.85%
1/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
Other adverse events
| Measure |
Liposomal Amphotericin B
n=237 participants at risk
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
Placebo
n=118 participants at risk
Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
49/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
22.9%
27/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.1%
50/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
22.0%
26/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.9%
40/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
22.0%
26/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.7%
42/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
11.9%
14/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Cardiac disorders
Tachycardia
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
6.8%
8/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
14/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
6.8%
8/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Nausea
|
49.8%
118/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
42.4%
50/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
75/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
36.4%
43/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
74/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
33.9%
40/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.8%
66/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
30.5%
36/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.2%
55/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
29.7%
35/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.5%
39/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
11.9%
14/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.6%
18/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
10.2%
12/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
14/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
9.3%
11/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
14/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Pyrexia
|
27.4%
65/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
31.4%
37/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Mucosal inflammation
|
25.7%
61/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
27.1%
32/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Oedema peripheral
|
23.6%
56/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
15.3%
18/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Asthenia
|
13.5%
32/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
16.1%
19/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Fatigue
|
7.2%
17/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
8.5%
10/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Chest pain
|
7.6%
18/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
6.8%
8/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Chills
|
7.2%
17/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Oedema
|
6.3%
15/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
General disorders
Pain
|
4.2%
10/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
9.3%
11/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.5%
6/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.9%
7/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Oral herpes
|
9.3%
22/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.9%
7/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Oral candidiasis
|
3.4%
8/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
9.3%
11/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Bacterial infection
|
5.1%
12/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Pneumonia
|
6.3%
15/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
2.5%
3/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Infections and infestations
Folliculitis
|
4.2%
10/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Antithrombin III decreased
|
13.9%
33/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
11.9%
14/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Blood fibrinogen decreased
|
8.0%
19/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
6.8%
8/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
17/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
19/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Blood bilirubin increased
|
6.8%
16/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Blood creatinine increased
|
8.4%
20/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
0.00%
0/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Investigations
Weight decreased
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
35.0%
83/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
17.8%
21/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.3%
22/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
9.3%
11/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.1%
24/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.6%
18/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.6%
18/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.9%
7/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Fluid retention
|
6.3%
15/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.1%
12/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
4.2%
5/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
34/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
13.6%
16/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
14/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
8/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
8.5%
10/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.6%
11/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Headache
|
35.4%
84/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
38.1%
45/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Dizziness
|
4.6%
11/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
10.2%
12/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
14/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
7.6%
9/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Psychiatric disorders
Insomnia
|
13.5%
32/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
14.4%
17/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Psychiatric disorders
Anxiety
|
8.0%
19/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
12.7%
15/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Psychiatric disorders
Depression
|
5.1%
12/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
4.2%
5/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Psychiatric disorders
Agitation
|
2.1%
5/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.9%
7/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.84%
2/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
29/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
14.4%
17/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.4%
20/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
13.6%
16/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
19/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
8.5%
10/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
15/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
11.0%
13/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.5%
39/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
9.3%
11/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
19/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
4.2%
5/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.2%
17/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.1%
6/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
13/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
3.4%
4/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Hypotension
|
7.2%
17/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
12.7%
15/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Hypertension
|
5.1%
12/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
5.9%
7/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
|
Vascular disorders
Haematoma
|
6.3%
15/237 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
2.5%
3/118 • From first dose to last dose of study drug plus 30 days.
Safety Analysis Set; participants who were randomized and received at least 1 dose of study drug. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER